The following data is part of a premarket notification filed by Philips Medical Systems, Nederland B.v. with the FDA for O-mar.
| Device ID | K143253 |
| 510k Number | K143253 |
| Device Name: | O-MAR |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Jan Van De Kerkhof |
| Correspondent | Susan Quick PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Clevland, OH 44143 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-04-09 |
| Summary: | summary |