Data / Medical devices / United States / Airon Corporation
Airon Corporation: FDA-registered device maker in Melbourne, FL, United States, 5 510(k) clearances
Airon Corporation is registered with the FDA (registration 3003697063) in Melbourne, FL, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 11, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003697063
- Address
- 751 North Dr Unit 6, Melbourne, FL, United States, 32934
- Owner or operator
- AIRON CORPORATION (9051096)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 20, 2007
- Registered through
- 2026
- Brand names listed
- Bacteria Filter, MACS CPAP System, pNeuton Mini Neo Ventilator, pNeuton Mini Ventilator, pNeuton Ventilator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 11, 2012 | K121379 | PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY | CBK | Substantially Equivalent | Airon Corporation | accessdata.fda.gov |
| June 20, 2008 | K080692 | MACS CPAP SYSTEM | BTL | Substantially Equivalent | Airon Corporation | accessdata.fda.gov |
| December 20, 2004 | K043085 | MODIFICATION TO: PNEUTON VENTILATOR | CBK | Substantially Equivalent | Airon Corporation | accessdata.fda.gov |
| June 3, 2003 | K024344 | PNEUTON VENTILATOR | CBK | Substantially Equivalent | Airon Corporation | accessdata.fda.gov |
| January 26, 1993 | K925217 | MERIDIAN MEDICAL SYSTEMS BREATHING FILTER | CAH | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Continuous, Facility Use
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Ventilator, Emergency, Powered (Resuscitator)
Updated October 11, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.