Data / Medical devices / Switzerland / Hamilton Medical AG
Hamilton Medical AG: FDA-registered device maker in Domat/Ems Graubunden, Switzerland, 10 510(k) clearances
Hamilton Medical AG is registered with the FDA (registration 3029906224) in Domat/Ems Graubunden, Switzerland. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 5, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029906224
- Address
- Parc Industrial Vial 12, Domat/Ems Graubunden, Switzerland, 7013
- Owner or operator
- Hamilton Medical AG (10059168)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 18, 2019
- 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 260169, PN 260170, Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244, Expiratory valve set , reusable, PN 161175, PN 161188, PN 151972, PN 160245, Expiratory valve set , single use, PN 160176, PN 161186, PN 161189, PN 950158, Flow sensor, single use, adult/pediatric PN 282051, PN 281637, PN 950185 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Air, Portable | BTI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 5, 2021 | K201306 | HAMILTON-C3 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| December 11, 2020 | K201658 | Hamilton-C6 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| May 4, 2020 | K193228 | Hamilton-G5 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| 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 |
| September 6, 2016 | K153046 | HAMILTON-MR1 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| May 3, 2016 | K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| January 29, 2016 | K150893 | IntelliCuff | BSK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| November 16, 2012 | K121225 | HAMILTON-C2 | CBK | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
| March 14, 2005 | K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | BTI | Substantially Equivalent | Hamilton Medical AG | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Ventilator, Continuous, Facility Use
- All makers of Oximeter
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
Updated February 5, 2021. 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.