The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Gyroview Hr High Resolution Workstation.
| Device ID | K896647 |
| 510k Number | K896647 |
| Device Name: | GYROVIEW HR HIGH RESOLUTION WORKSTATION |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | William Mcmahon |
| Correspondent | William 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 | 1989-11-24 |
| Decision Date | 1989-12-21 |