The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Crossvent-4 Ventilator.
| Device ID | K942938 |
| 510k Number | K942938 |
| Device Name: | CROSSVENT-4 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIO-MED DEVICES, INC. 1445 BOSTON POST RD. Guilford, CT 06437 |
| Contact | Dean J Bennett, Iii |
| Correspondent | Dean J Bennett, Iii BIO-MED DEVICES, INC. 1445 BOSTON POST RD. Guilford, CT 06437 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-22 |
| Decision Date | 1995-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813841021000 | K942938 | 000 |
| 00813841020744 | K942938 | 000 |
| 00813841020737 | K942938 | 000 |
| 00813841020720 | K942938 | 000 |
| 00813841020713 | K942938 | 000 |
| 00813841020706 | K942938 | 000 |
| 00813841020690 | K942938 | 000 |
| 00813841020683 | K942938 | 000 |
| 00813841020676 | K942938 | 000 |
| 00813841020669 | K942938 | 000 |
| 00813841020751 | K942938 | 000 |
| 00813841020768 | K942938 | 000 |
| 00813841020997 | K942938 | 000 |
| 00813841020843 | K942938 | 000 |
| 00813841020836 | K942938 | 000 |
| 00813841020829 | K942938 | 000 |
| 00813841020812 | K942938 | 000 |
| 00813841020805 | K942938 | 000 |
| 00813841020799 | K942938 | 000 |
| 00813841020782 | K942938 | 000 |
| 00813841020775 | K942938 | 000 |
| 00813841020652 | K942938 | 000 |