The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Integris V5000 And Bv5000.
Device ID | K973482 |
510k Number | K973482 |
Device Name: | PHILIPS INTEGRIS V5000 AND BV5000 |
Classification | System, X-ray, Angiographic |
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 | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-15 |
Decision Date | 1997-11-10 |
Summary: | summary |