The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Ratational Angiography Option For Philips Multidiagnost 4.
| Device ID | K971489 |
| 510k Number | K971489 |
| Device Name: | RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4 |
| Classification | System, X-ray, Angiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 -0197 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 -0197 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-07-03 |
| Summary: | summary |