The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Universal Vol. Ventilator 72 #1626.
| Device ID | K832681 |
| 510k Number | K832681 |
| Device Name: | UNIVERSAL VOL. VENTILATOR 72 #1626 |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 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 | 1983-08-09 |
| Decision Date | 1983-09-26 |