The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Odyssey Lx, Model 211320.
| Device ID | K003437 |
| 510k Number | K003437 |
| Device Name: | ODYSSEY LX, MODEL 211320 |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Ronald J Martone |
| Correspondent | Ronald J Martone PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2001-02-02 |