The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Saf T Flo Ventilator Tubing.
| Device ID | K850703 |
| 510k Number | K850703 |
| Device Name: | SAF T FLO VENTILATOR TUBING |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Shapiro |
| Correspondent | Shapiro BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-03-25 |