MR 5300

System, Nuclear Magnetic Resonance Imaging

Philips Medical Systems Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Mr 5300.

Pre-market Notification Details

Device IDK212673
510k NumberK212673
Device Name:MR 5300
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684pc
ContactJan Van De Kerkhof
CorrespondentJan Van De Kerkhof
Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684pc
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-24
Decision Date2021-11-19

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