The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Syncra Tilt Option For Angio Diagnost 5.
Device ID | K940696 |
510k Number | K940696 |
Device Name: | SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 |
Classification | Table, Radiologic |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | Peter Altman |
Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-16 |
Decision Date | 1994-03-16 |