The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Cd Medical Recorder, View Station, Dup[[lication Station.
Device ID | K945460 |
510k Number | K945460 |
Device Name: | PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | Peter Altman |
Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-07 |
Decision Date | 1995-03-14 |