The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Universix 120.
| Device ID | K954196 |
| 510k Number | K954196 |
| Device Name: | UNIVERSIX 120 |
| Classification | System, X-ray, Stationary |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Robert L Turocy PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-10-24 |