The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Ventilator Circuit.
| Device ID | K812774 |
| 510k Number | K812774 |
| Device Name: | VENTILATOR CIRCUIT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-05 |
| Decision Date | 1981-10-23 |