The following data is part of a premarket notification filed by Microbvm Systems Ltd with the FDA for Pocket Bvm.
| Device ID | K093081 |
| 510k Number | K093081 |
| Device Name: | POCKET BVM |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MICROBVM SYSTEMS LTD POB 6718 Efrat, IL 90435 |
| Contact | Eli Orbach |
| Correspondent | Eli Orbach MICROBVM SYSTEMS LTD POB 6718 Efrat, IL 90435 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-02-05 |
| Summary: | summary |