The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Dsp Option.
| Device ID | K945580 |
| 510k Number | K945580 |
| Device Name: | DSP OPTION |
| Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
| 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 | IZJ |
| CFR Regulation Number | 892.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-01-30 |