The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Tomoscan Sr 8000.
Device ID | K954255 |
510k Number | K954255 |
Device Name: | PHILIPS TOMOSCAN SR 8000 |
Classification | System, X-ray, Tomography, Computed |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | Timothy W Capehart |
Correspondent | Timothy W Capehart PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-11 |
Decision Date | 1995-10-07 |