The following data is part of a premarket notification filed by Airon Corporation with the FDA for Modification To: Pneuton Ventilator.
| Device ID | K043085 |
| 510k Number | K043085 |
| Device Name: | MODIFICATION TO: PNEUTON VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | AIRON CORPORATION 17 EAST MELBOURNE AVE. Melbourne, FL 32901 |
| Contact | Eric Gjerde |
| Correspondent | Eric Gjerde AIRON CORPORATION 17 EAST MELBOURNE AVE. Melbourne, FL 32901 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853678006009 | K043085 | 000 |