The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Srs-200 Radiosurgery System.
Device ID | K891292 |
510k Number | K891292 |
Device Name: | SRS-200 RADIOSURGERY SYSTEM |
Classification | Accelerator, Linear, Medical |
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 | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-10 |
Decision Date | 1989-09-18 |