Gem-Med S.L.
SpainFDA applicant, unverified
- Devices
- 1
What Gem-Med S.L. makes
Gem-Med S.L. manufactures the GEM HEART ONE and GEM HEART ONE+ devices, which are external cardiac defibrillators designed for automated or semi-automated shock delivery in cardiac arrest emergencies.
These devices fall under FDA Class II regulation and are listed via the 510(k) clearance pathway in the United States. The company is based in the US.
Catalogue
Gem Heart One/One+ Ref K092576
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gem-Med S.L. have in the registry?
The registry currently lists 1 device for Gem-Med S.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gem-Med S.L.'s devices?
Among its 1 most recently registered device, Gem-Med S.L. has devices listed in FDA 510(k) (1 device).
What risk classes do Gem-Med S.L.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gem-Med S.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gem-Med S.L. in the registry?
The most recently registered devices listed for Gem-Med S.L. include GEM HEART ONE/ONE+.