AMRA Profiler
K-Number: K211983 · 2021-11-24
ApplicantAmra Medical AB
Decision Date2021-11-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AMRA Profiler is a medical device manufactured by Amra Medical AB. It received FDA 510(k) clearance on 2021-11-24 under approval number K211983. 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 AMRA Profiler?
AMRA Profiler is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Amra Medical AB. The 510(k) number is K211983.
When was AMRA Profiler approved by the FDA?
AMRA Profiler received FDA 510(k) clearance on 2021-11-24, under approval number K211983.
What company makes AMRA Profiler?
AMRA Profiler is manufactured by Amra Medical AB.
What is the FDA product code for AMRA Profiler?
The FDA product code for AMRA Profiler is LNH.
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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.