Icare Newlife Technologies, Inc.
ChinaFDA applicant, unverified
- Devices
- 1
What Icare Newlife Technologies, Inc. makes
Icare Newlife Technologies, Inc. manufactures a fetal Doppler, a handheld ultrasound device used to detect fetal heartbeats during pregnancy.
The fetal Doppler is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Fetal Doppler Ref K142769
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Icare Newlife Technologies, Inc. have in the registry?
The registry currently lists 1 device for Icare Newlife Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icare Newlife Technologies, Inc.'s devices?
Among its 1 most recently registered device, Icare Newlife Technologies, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Icare Newlife Technologies, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Icare Newlife Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Icare Newlife Technologies, Inc. in the registry?
The most recently registered devices listed for Icare Newlife Technologies, Inc. include Fetal Doppler.