BiWaze Cough— 510(k) K191912

Substantially Equivalent

Abmrc, LLC

FDA 510(k) clearance K191912 for BiWaze Cough, Substantially Equivalent on 2020-03-27. Applicant: Abmrc, LLC.

Clearance details

Applicant: Abmrc, LLC
Product code: Code NHJ
Advisory panel: Anesthesiology
Date received: 2019-07-17
Decision date: 2020-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charleston, SC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.