ProxiDiagnost N90
K-Number: K212837 · 2021-09-21
ApplicantPhilips Medical Systems Dmc GmbH
Decision Date2021-09-21
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ProxiDiagnost N90 is a medical device manufactured by Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2021-09-21 under approval number K212837. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProxiDiagnost N90?
ProxiDiagnost N90 is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Philips Medical Systems Dmc GmbH. The 510(k) number is K212837.
When was ProxiDiagnost N90 approved by the FDA?
ProxiDiagnost N90 received FDA 510(k) clearance on 2021-09-21, under approval number K212837.
What company makes ProxiDiagnost N90?
ProxiDiagnost N90 is manufactured by Philips Medical Systems Dmc GmbH.
What is the FDA product code for ProxiDiagnost N90?
The FDA product code for ProxiDiagnost N90 is JAA.
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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.