K191912 is an FDA 510(k) clearance for the BiWaze Cough. This device is classified as a Device, Positive Pressure Breathing, Intermittent (Class II - Special Controls, product code NHJ).
Submitted by Abmrc, LLC (Charleston, US). The FDA issued a Cleared decision on March 27, 2020, 254 days after receiving the submission on July 17, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K191912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2019 |
| Decision Date | March 27, 2020 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NHJ - Device, Positive Pressure Breathing, Intermittent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |