The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Volume Ventilator Circuit W/water Trap.
| Device ID | K834570 |
| 510k Number | K834570 |
| Device Name: | VOLUME VENTILATOR CIRCUIT W/WATER TRAP |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | AIRLIFE, 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 | 1983-12-29 |
| Decision Date | 1984-03-05 |