Data / Medical devices / France / Int'air Medical
Int'air Medical: FDA-registered device maker in MONTAGNAT Ain, France, 2 510(k) clearances
Int'air Medical is registered with the FDA (registration 3030149975) in MONTAGNAT Ain, France. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 2, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030149975
- Address
- 868 Chemin De La Za Des Metrillots, MONTAGNAT Ain, France, 01250
- Owner or operator
- INT'AIR MEDICAL (10091244)
- Roles
- Exporter to the US
- First device listed
- July 31, 2024
- Registered through
- 2026
- Brand names listed
- Breathing circuit set, coaxial, single use, adult/pediatric PN 260094, PN 260127, PN 260128, PN 260184, PN 260206, Breathing circuit set, coaxial, single use, adult/pediatric PN 260167, PN 260168, PN 260145, PN 260144, PN 260087, Breathing circuit set, coaxial, single use, adult/pediatric PN 260207, PN 260239, PN 260240, PN 260257, Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 250169, PN 260170, Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244, Cover Plug for ID15, Red Cover Cap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Exporter to the US | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Exporter to the US | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Exporter to the US | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Exporter to the US | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| September 20, 2017 | K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Oximeter
- All makers of Ventilator, Continuous, Facility Use
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Updated August 2, 2019. 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.