The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Tracheostoma Vent.
| Device ID | K810436 |
| 510k Number | K810436 |
| Device Name: | TRACHEOSTOMA VENT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-19 |
| Decision Date | 1981-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35021312009952 | K810436 | 000 |
| 35021312009778 | K810436 | 000 |
| 35021312009785 | K810436 | 000 |
| 35021312009792 | K810436 | 000 |
| 35021312009808 | K810436 | 000 |
| 35021312009815 | K810436 | 000 |
| 35021312009822 | K810436 | 000 |
| 35021312009839 | K810436 | 000 |
| 35021312009853 | K810436 | 000 |
| 35021312009860 | K810436 | 000 |
| 35021312009877 | K810436 | 000 |
| 35021312009884 | K810436 | 000 |
| 35021312009907 | K810436 | 000 |
| 35021312009914 | K810436 | 000 |
| 35021312009921 | K810436 | 000 |
| 35021312009761 | K810436 | 000 |