The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Nicol Collimator Family.
| Device ID | K990423 |
| 510k Number | K990423 |
| Device Name: | PHILIPS NICOL COLLIMATOR FAMILY |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 Shelton, CT 06484 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-11 |
| Decision Date | 1999-03-15 |
| Summary: | summary |