The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Universix 190.
| Device ID | K953402 |
| 510k Number | K953402 |
| Device Name: | UNIVERSIX 190 |
| Classification | Holder, Radiographic Cassette, Wall-mounted |
| 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 | IXY |
| CFR Regulation Number | 892.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-08-11 |