The following data is part of a premarket notification filed by Narco Scientific with the FDA for Pz-800 Volume Ventilator.
| Device ID | K822835 |
| 510k Number | K822835 |
| Device Name: | PZ-800 VOLUME VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NARCO SCIENTIFIC MD |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-21 |
| Decision Date | 1983-09-29 |