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 a medical device manufactured by Abmrc, LLC. It received FDA 510(k) clearance on 2020-03-27 under approval 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. It is manufactured by Abmrc, LLC. The 510(k) number is K191912.
When was BiWaze Cough approved by the FDA?
BiWaze Cough received FDA 510(k) clearance on 2020-03-27, under approval number K191912.
What company makes BiWaze Cough?
BiWaze Cough is manufactured by Abmrc, LLC.
What is the FDA product code for BiWaze Cough?
The FDA product code for BiWaze Cough is NHJ.
Related Clinical Trials
Other Devices by Abmrc, LLC
Related Devices (Code: NHJ)
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.