The following data is part of a premarket notification filed by Airon Corporation with the FDA for Pneuton Ventilator.
| Device ID | K024344 |
| 510k Number | K024344 |
| Device Name: | PNEUTON VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | AIRON CORPORATION 102 EAST NEW HAVEN AVE. #146 Melbourne, FL 32901 |
| Contact | G. Eric Gjerde |
| Correspondent | G. Eric Gjerde AIRON CORPORATION 102 EAST NEW HAVEN AVE. #146 Melbourne, FL 32901 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-27 |
| Decision Date | 2003-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853678006641 | K024344 | 000 |
| 00853678006092 | K024344 | 000 |
| 00853678006061 | K024344 | 000 |
| 00853678006016 | K024344 | 000 |