and rate pressure product (RPP) are provided in Tables 8, 9, 12 and l3. ......
jigsaw. Page 88 - NDA_l_9-386. Addendum to the Clinical Pharmacology (
Section I!
the AMX-3 Mobile X-ray System, K802047. The AMX-4 Plus Mobile X-ray ... In the
opinion of GE Medical Systems, the AMX-4 Plus Mobile X- ray System is ...
D. Type of Test: Ion Selective Electrode. E. Applicant: Diamond Diagnostics, Inc.
F. Proprietary and Established Names: PROLYTE Electrolyte Analyzer Na. +. /K.
The VITEK. ®. MS is manufactured for bioMérieux by Kratos Analytical (a ...
MylaTM interfaces between the bioMérieux instruments ..... chromID CPS. 43541
/ ...
Oct 25, 2011 ... Amsco V-PRO maX Low Temperature Sterilization. System ... model to be added
to the Amsco V-PRO family of sterilizers. The V-PRO product.
Apr 29, 2013 ... Scanora 3Dx is a Cone Beam Computerized Tomography x-ray system for.
F1901 596300006864. Dentomaxillofacial and Head & Neck (ENT) ...
Newton, MA 02460 USA. Phone: 617-926- .... NMP22 Tri-Level Controls 3 x 2 mL
(lyophllized). Contains .... Stopthecoiordeveiopmentraadionbyadd'ng
SOuUWetloIM-lN)H=SO4. StopSolution ..... Phone: M2521 or 617-928—0620.
Fax: liT-IZB- ...
Regulation Number: 21 CFR 892.1710. Regulation Name: Mammographic x-ray
system. Regulatory Class: II. Product Code: IYX and IZH. Dated: July 26, 2006.
Erbe ICC 200. Erbe ICC 50. ZoMed. VidaMed. The SomnusTM Model 225
Electrosurgical Generator is an electrosurgical generator has controls for power ...
DIFLUCAN is a tablet you swallow to treat vaginal yeast infections caused by a
yeast ... DIFLUCAN is different from other treatments for vaginal yeast infections ...
F. Proprietary and Established Names: COBAS INTEGRA 800 Tina-quant.
HbA1cDx ... blood on the Roche COBAS INTEGRA 800 clinical chemistry
analyzer. 2.
Aug 24, 2011 ... Preferred Code Oxylog 3000 plus: 868.5895. Ventilator, continuous,. CBK. Code
for predicates (Oxylog 3000, Oxylog 2000 plus and Oxalog ...
Jul 15, 2009 ... The MySono US is a hand-held, software controlled, diagnostic ultrasound ... The
MySono U5 has been designed to meet the following product ...
Apr 5, 2010 ... Quantel Medical AXIS II Ultrasonic Biometer (K000554). Description ... EN 6060 1
-1-2:2002 Medical Electrical Equipment Collateral. Standard: ...
23 Sep 2010 ... South Barrington, Illinois 60010. Re: K102761. Trade/Device Name: Reusable
SteriScan Integrator Test Pack for Steamn. Regulation Number: ...
5 Feb 1996 ... Bayer Corporation, Business Group Diagnostics. CLINITEK® 50 Urine Chemistry
Analyzer. 510(k) Safety and Effectiveness Summary.
Modification for body fluid application for ADVIA 2120 and the ADVIA 2120i. ...
Application uses the ADVIA 120 CBC TIMEpac and ADVIA 120 Diff TIMEpac.
Jan 25, 2012 ... Philips Respironics ... V60 Ventilator ... The Respironics BiPAP A30 Ventilatory
Support System is a microprocessor controlled blower based.
Sep 27, 2012 ... The Siemens ACUSON X700 TM Ultrasound System is a multi-purpose ... The
Siemens ACUSON X7 00 TM is a multi-purpose mobile, software ...
Dec 6, 2013 ... W164 N19221 Water Street. Menomonee Falls ... provides an audible and visual
indication that the cavity temperature has exceeded the set.
Dec 11, 2006 ... 462-440-01 Fosphenytoin, 100 mg PE in 2 mL, 25 x 2 mL Shelf Pack Label. Size:
1 7/8” x 2 3/4” ... Prints in PMS 3272 and 287. Guide Lines.
To obtain a substantial equivalent determination for a premarket notification for
the. BD BACTEC Plus Aerobic/F blood culture medium in plastic bottles.
Mar 18, 2011 ... 1. GENERAL INFORMATION. ANTHOGYR (Registration number 8020776) ... /
ISO 15223-1 (2007) 'Medical devices - Symbols to be used with ...
Oct 4, 2013 ... Robert Bosch Healthcare Systems, Inc. ... Trade name: Bosch Blood Pressure
Monitor (BP5000 BT) .... Traditional 510(k), Apr 10P', 2013.
Trichophyron rubrum; this can cause tinea corporis,' tinea pedis, tinea manuum,
and onychomycosis.' The organism that is the second most commonly isolated ...