The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Nuffield Anesthesia Ventilator Ser. 400.
| Device ID | K803052 |
| 510k Number | K803052 |
| Device Name: | NUFFIELD ANESTHESIA VENTILATOR SER. 400 |
| Classification | Gas-machine, Anesthesia |
| Applicant | PENLON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-02 |
| Decision Date | 1981-01-07 |