The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Integris I 2000 System.
| Device ID | K904012 |
| 510k Number | K904012 |
| Device Name: | PHILIPS INTEGRIS I 2000 SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Contact | Kelly A Diaz |
| Correspondent | Kelly A Diaz PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-29 |
| Decision Date | 1990-11-29 |