ProxiDiagnost N90 / Precision CRF (706110, 706400)
K-Number: K233945 · 2024-01-11
ApplicantPhilips Medical Systems Dmc GmbH
Decision Date2024-01-11
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ProxiDiagnost N90 / Precision CRF (706110, 706400) is a medical device manufactured by Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2024-01-11 under approval number K233945. 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 / Precision CRF (706110, 706400)?
ProxiDiagnost N90 / Precision CRF (706110, 706400) is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Philips Medical Systems Dmc GmbH. The 510(k) number is K233945.
When was ProxiDiagnost N90 / Precision CRF (706110, 706400) approved by the FDA?
ProxiDiagnost N90 / Precision CRF (706110, 706400) received FDA 510(k) clearance on 2024-01-11, under approval number K233945.
What company makes ProxiDiagnost N90 / Precision CRF (706110, 706400)?
ProxiDiagnost N90 / Precision CRF (706110, 706400) is manufactured by Philips Medical Systems Dmc GmbH.
What is the FDA product code for ProxiDiagnost N90 / Precision CRF (706110, 706400)?
The FDA product code for ProxiDiagnost N90 / Precision CRF (706110, 706400) is JAA.
Other Devices by Philips Medical Systems Dmc GmbH
Related Devices (Code: JAA)
K161019Uroview FDPausch Medical GmbH
K160301Platinum dRF Imaging SystemApelem-Dms Group
K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH
K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A
K180651Uroview FD IIPausch Medical GmbH
K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.
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.