The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Pneupac Oxygen Therapy Unit.
| Device ID | K792453 |
| 510k Number | K792453 |
| Device Name: | PNEUPAC OXYGEN THERAPY UNIT |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | PNEU PAC, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-03 |
| Decision Date | 1980-02-05 |