The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Bv 300 Series.
Device ID | K953910 |
510k Number | K953910 |
Device Name: | PHILIPS BV 300 SERIES |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
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 | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-21 |
Decision Date | 1995-10-18 |
Summary: | summary |