The following data is part of a premarket notification filed by Abmrc Llc with the FDA for Biwaze Cough.
| Device ID | K191912 |
| 510k Number | K191912 |
| Device Name: | BiWaze Cough |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | ABMRC LLC 239, Fair Child Street, Daniel Island Charleston, SC 29492 |
| Contact | Chad M Boerst |
| Correspondent | Sneha S P ABMRC LLC 239, Fair Child Street, Daniel Island Charleston, SC 29492 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-17 |
| Decision Date | 2020-03-27 |