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FDA 510(k)

BiWaze Cough

K-Number: K191912 · 2020-03-27

ApplicantAbmrc, LLC
Decision Date2020-03-27
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BiWaze Cough is the device name listed in this FDA 510(k) record. The listed applicant is Abmrc, LLC. It received FDA 510(k) clearance on 2020-03-27 under 510(k) number K191912. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BiWaze Cough?

BiWaze Cough is a medical device that received FDA 510(k) clearance on 2020-03-27. The listed applicant is Abmrc, LLC. The 510(k) number is K191912.

When did BiWaze Cough receive FDA 510(k) clearance?

BiWaze Cough received FDA 510(k) clearance on 2020-03-27, under 510(k) number K191912.

Who is the listed applicant for BiWaze Cough?

The FDA 510(k) record lists Abmrc, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BiWaze Cough?

The FDA product code for BiWaze Cough is NHJ.

Related Clinical Trials

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.

NCT06119087Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) StudyCOMPLETED

Other records listing Abmrc, LLC 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.

K231728BiWaze Clear SystemK213564BiWaze Clear System

Related Devices (Code: NHJ)

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.

K253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K242438ClearoBreas Medical ABK231728BiWaze Clear SystemAbmrc, LLCK213564BiWaze Clear SystemAbmrc, LLCK200988Maximus SystemHill-Rom Services Pte, Ltd.K192143Maximus SystemHill-Rom Services Pte, Ltd.

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.

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