The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Pneu Pac Ventilator/resuscitators.
| Device ID | K832700 |
| 510k Number | K832700 |
| Device Name: | PNEU PAC VENTILATOR/RESUSCITATORS |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PNEU PAC, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-10 |
| Decision Date | 1983-11-14 |