The following data is part of a premarket notification filed by Safe Bvm Corporation with the FDA for Sotair Device.
| Device ID | K212905 |
| 510k Number | K212905 |
| Device Name: | Sotair Device |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | Safe BVM Corporation 1120 Weidman Road Chesterfield, MO 63017 |
| Contact | Haris Shekhani |
| Correspondent | Sara Toyloy Fabrica Consulting, LLC 73 Lincoln Drive Sausalito, CA 94965 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2022-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006979607 | K212905 | 000 |