AMRA Profiler
K-Number: K173749 · 2018-12-06
ApplicantAmra Medical AB
Decision Date2018-12-06
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 2018-12-06 under approval number K173749. 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 2018-12-06. It is manufactured by Amra Medical AB. The 510(k) number is K173749.
When was AMRA Profiler approved by the FDA?
AMRA Profiler received FDA 510(k) clearance on 2018-12-06, under approval number K173749.
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.
Other Devices by Amra Medical AB
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
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.