Onepass Medical, Ltd.
IsraelFDA 510(k) applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Onepass Medical, Ltd. makes
Onepass Medical, Ltd. manufactures the InstaFAN, a medical device designed for rapid and efficient cooling of patients, likely used in critical care or therapeutic hypothermia applications.
The InstaFAN is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
InstaFAN Ref K251542
510(k) 510(k)
FDA establishments
- Onepass Medical Ltd Katzrin Northern · IL FEI 3043585886
Frequently asked questions
How many devices does Onepass Medical, Ltd. have in the registry?
The registry currently lists 1 device for Onepass Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Onepass Medical, Ltd.'s devices?
Among its 1 most recently registered device, Onepass Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Onepass Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Onepass Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Onepass Medical, Ltd. in the registry?
The most recently registered devices listed for Onepass Medical, Ltd. include InstaFAN.
Which FDA establishments are linked to Onepass Medical, Ltd.?
1 FDA establishment is linked to Onepass Medical, Ltd. in the registry; they are listed on the company page.