The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Tv-100.
| Device ID | K173973 |
| 510k Number | K173973 |
| Device Name: | TV-100 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | Bio-Med Devices, Inc. 61 Soundview Road Guilford, CT 06437 |
| Contact | Ken Close |
| Correspondent | Paul Dryden Bio-Med Devices C/o ProMedic, LLC 61 Soundview Road Guilford, CT 06437 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-07-20 |
| Summary: | summary |