The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Gyroview Hr - Release 2.
Device ID | K923944 |
510k Number | K923944 |
Device Name: | PHILIPS GYROVIEW HR - RELEASE 2 |
Classification | System, Nuclear Magnetic Resonance Imaging |
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 | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-05 |
Decision Date | 1993-04-27 |