The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Pneupac Ventilator/resuscitator #2.
| Device ID | K792455 |
| 510k Number | K792455 |
| Device Name: | PNEUPAC VENTILATOR/RESUSCITATOR #2 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PNEU PAC, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-03 |
| Decision Date | 1980-02-05 |