The following data is part of a premarket notification filed by Philips Medical Systems Nethrlands Bv with the FDA for Multiband Sense.
Device ID | K143606 |
510k Number | K143606 |
Device Name: | MultiBand SENSE |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | PHILIPS MEDICAL SYSTEMS NETHRLANDS BV 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 44143 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-19 |
Decision Date | 2015-05-08 |
Summary: | summary |