The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Bivona Ventilator Isolator System.
| Device ID | K890499 |
| 510k Number | K890499 |
| Device Name: | BIVONA VENTILATOR ISOLATOR SYSTEM |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Contact | Harry M Kaufman |
| Correspondent | Harry M Kaufman BIVONA MEDICAL TECHNOLOGIES 5700 WEST 23RD AVE. Gary, IN 46406 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-01 |
| Decision Date | 1989-06-15 |