The following data is part of a premarket notification filed by Penlon Ltd. with the FDA for Av 800 Ventilator.
| Device ID | K010317 |
| 510k Number | K010317 |
| Device Name: | AV 800 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PENLON LTD. RADLEY ROAD ABINGDON Oxfordshire, GB Ox14 3ph |
| Contact | Anthony Parsons |
| Correspondent | Anthony Parsons PENLON LTD. RADLEY ROAD ABINGDON Oxfordshire, GB Ox14 3ph |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-02 |
| Decision Date | 2001-07-23 |