The following data is part of a premarket notification filed by Avatron, Inc. with the FDA for Avatron Universal Adult Vol. Ventilator.
| Device ID | K842778 |
| 510k Number | K842778 |
| Device Name: | AVATRON UNIVERSAL ADULT VOL. VENTILATOR |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | AVATRON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-16 |
| Decision Date | 1984-07-26 |