FDA 510(k)

NR Recorder

K-Number: K161062 · 2016-06-13

Decision Date2016-06-13

Product CodeMWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NR Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical GmbH. It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K161062. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NR Recorder?

NR Recorder is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Norav Medical GmbH. The 510(k) number is K161062.

When did NR Recorder receive FDA 510(k) clearance?

NR Recorder received FDA 510(k) clearance on 2016-06-13, under 510(k) number K161062.

Who is the listed applicant for NR Recorder?

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

What is the FDA product code for NR Recorder?

The FDA product code for NR Recorder is MWJ.

Related Devices (Code: MWJ)

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.

K253562medilogFDSchiller AG K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd.

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.