MR 5300
K-Number: K212673 · 2021-11-19
Decision Date2021-11-19
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MR 5300 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2021-11-19 under approval number K212673. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MR 5300?
MR 5300 is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K212673.
When was MR 5300 approved by the FDA?
MR 5300 received FDA 510(k) clearance on 2021-11-19, under approval number K212673.
What company makes MR 5300?
MR 5300 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for MR 5300?
The FDA product code for MR 5300 is LNH.
Other Devices by Philips Medical Systems Nederland B.V.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.