The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Duo Diagnost.
Device ID | K983069 |
510k Number | K983069 |
Device Name: | PHILIPS DUO DIAGNOST |
Classification | Interventional Fluoroscopic X-ray System |
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 | OWB |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-02 |
Decision Date | 1998-11-02 |
Summary: | summary |