The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Release 2 Of Philips Integris Series (v5000, Bv5000, H5000, Bh5000, Hm2000) Systems.
| Device ID | K984545 |
| 510k Number | K984545 |
| Device Name: | RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS |
| Classification | System, X-ray, Angiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL 5680 |
| Contact | P. Altman |
| Correspondent | P. Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL 5680 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-22 |
| Decision Date | 1999-02-25 |
| Summary: | summary |