FDA 510(k)

AMRA Profiler

K-Number: K173749 · 2018-12-06

Decision Date2018-12-06

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AMRA Profiler is the device name listed in this FDA 510(k) record. The listed applicant is Amra Medical AB. It received FDA 510(k) clearance on 2018-12-06 under 510(k) 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. The listed applicant is Amra Medical AB. The 510(k) number is K173749.

When did AMRA Profiler receive FDA 510(k) clearance?

AMRA Profiler received FDA 510(k) clearance on 2018-12-06, under 510(k) number K173749.

Who is the listed applicant for AMRA Profiler?

The FDA 510(k) record lists Amra Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMRA Profiler?

The FDA product code for AMRA Profiler is LNH.

Other records listing Amra Medical AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211983AMRA Profiler

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.