The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Site View Workstation.
Device ID | K960809 |
510k Number | K960809 |
Device Name: | PHILIPS SITE VIEW WORKSTATION |
Classification | System, Digital Image Communications, Radiological |
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 | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-28 |
Decision Date | 1996-04-07 |