The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Multiband Sense.
| Device ID | K162940 |
| 510k Number | K162940 |
| Device Name: | MultiBand SENSE |
| 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 Cleveland, OH 44094 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-21 |
| Decision Date | 2016-12-30 |
| Summary: | summary |