The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Bv-29 Imaging System.
| Device ID | K910115 |
| 510k Number | K910115 |
| Device Name: | PHILIPS BV-29 IMAGING SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Contact | William G Mcmahon |
| Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-10 |
| Decision Date | 1991-02-20 |