The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Penlon Am1000 Anaesthesia Machine.
| Device ID | K844008 |
| 510k Number | K844008 |
| Device Name: | PENLON AM1000 ANAESTHESIA MACHINE |
| Classification | Gas-machine, Anesthesia |
| Applicant | PENLON, INC. ABINGDON OX14 3PH England, GB |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-12 |
| Decision Date | 1985-03-12 |