The following data is part of a premarket notification filed by Airon Corporation with the FDA for Pneuton Mini Ventilator Pneuton Mini Non-invasive Ventilation (niv) Kit Accessory.
| Device ID | K121379 |
| 510k Number | K121379 |
| Device Name: | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | AIRON CORPORATION 751 North Dr Ste 6 Melbourne, FL 32934 |
| Contact | G. Eric Gjerde |
| Correspondent | G. Eric Gjerde AIRON CORPORATION 751 North Dr Ste 6 Melbourne, FL 32934 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-08 |
| Decision Date | 2012-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853678006627 | K121379 | 000 |
| 00853678006306 | K121379 | 000 |
| 00853678006283 | K121379 | 000 |
| 00853678006269 | K121379 | 000 |
| 00853678006238 | K121379 | 000 |
| 00853678006221 | K121379 | 000 |
| 00853678006207 | K121379 | 000 |
| 00853678006184 | K121379 | 000 |
| 00853678006160 | K121379 | 000 |
| 00853678006146 | K121379 | 000 |
| 00853678006115 | K121379 | 000 |
| 00853678006023 | K121379 | 000 |
| 00853678006696 | K121379 | 000 |
| 00853678006320 | K121379 | 000 |
| 00853678006344 | K121379 | 000 |
| 00853678006368 | K121379 | 000 |
| 00853678006603 | K121379 | 000 |
| 00853678006580 | K121379 | 000 |
| 00853678006566 | K121379 | 000 |
| 00853678006542 | K121379 | 000 |
| 00853678006528 | K121379 | 000 |
| 00853678006504 | K121379 | 000 |
| 00853678006481 | K121379 | 000 |
| 00853678006467 | K121379 | 000 |
| 00853678006443 | K121379 | 000 |
| 00853678006429 | K121379 | 000 |
| 00853678006405 | K121379 | 000 |
| 00853678006382 | K121379 | 000 |
| 00853678006719 | K121379 | 000 |