The following data is part of a premarket notification filed by Penlon Limited with the FDA for Av-s Anaesthesia Ventilator.
| Device ID | K051222 |
| 510k Number | K051222 |
| Device Name: | AV-S ANAESTHESIA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PENLON LIMITED Abingdon Science Park Barton Lane, Abingdon Oxon, GB Ox14 3nb |
| Contact | Barry Pearce |
| Correspondent | Barry Pearce PENLON LIMITED Abingdon Science Park Barton Lane, Abingdon Oxon, GB Ox14 3nb |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2005-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051977000567 | K051222 | 000 |
| 05051977000055 | K051222 | 000 |
| 05051977000048 | K051222 | 000 |