The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Angiopro.
Device ID | K911888 |
510k Number | K911888 |
Device Name: | PHILIPS ANGIOPRO |
Classification | Programmer, Changer, Film/cassette, Radiographic |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | William G Mcmahon |
Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | IZP |
CFR Regulation Number | 892.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-29 |
Decision Date | 1991-10-15 |