Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K945460
Device Name PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Applicant Contact PETER ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 BRIDGEPORT AVE.
SHELTON,  CT  06484
Correspondent Contact PETER ALTMAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received11/07/1994
Decision Date 03/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-