Safkan, Inc.
Country not established
- Devices
- 1
What Safkan, Inc. makes
Safkan, Inc. manufactures the OtoSet Ear Cleaning System, a device designed for manual or automated removal of earwax and debris from the external ear canal.
The OtoSet Ear Cleaning System is classified as a Class I medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
OtoSet- Ear Cleaning System Ref K201877
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Safkan, Inc. have in the registry?
The registry currently lists 1 device for Safkan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safkan, Inc.'s devices?
Among its 1 most recently registered device, Safkan, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Safkan, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Safkan, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Safkan, Inc. in the registry?
The most recently registered devices listed for Safkan, Inc. include OtoSet- Ear Cleaning System.