The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Sli Series Linear Accelerator.
Device ID | K963624 |
510k Number | K963624 |
Device Name: | PHILIPS SLI SERIES LINEAR ACCELERATOR |
Classification | Accelerator, Linear, Medical |
Applicant | PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
Contact | Peter Altman |
Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 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 | 1996-09-11 |
Decision Date | 1996-12-06 |
Summary: | summary |