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FDA 510(k)

BiWaze Clear System

K-Number: K231728 · 2024-04-08

ApplicantAbmrc, LLC
Decision Date2024-04-08
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BiWaze Clear System is the device name listed in this FDA 510(k) record. The listed applicant is Abmrc, LLC. It received FDA 510(k) clearance on 2024-04-08 under 510(k) number K231728. 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 Clear System?

BiWaze Clear System is a medical device that received FDA 510(k) clearance on 2024-04-08. The listed applicant is Abmrc, LLC. The 510(k) number is K231728.

When did BiWaze Clear System receive FDA 510(k) clearance?

BiWaze Clear System received FDA 510(k) clearance on 2024-04-08, under 510(k) number K231728.

Who is the listed applicant for BiWaze Clear System?

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 Clear System?

The FDA product code for BiWaze Clear System 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.

NCT06926881OLE Therapy With BE Patients in Home Care StudyRECRUITING

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.

K213564BiWaze Clear SystemK191912BiWaze Cough

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 ABK213564BiWaze Clear SystemAbmrc, LLCK200988Maximus SystemHill-Rom Services Pte, Ltd.K191912BiWaze CoughAbmrc, LLCK192143Maximus SystemHill-Rom Services Pte, 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.

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