Cool Baby, Inc.
Country not established
- Devices
- 1
What Cool Baby, Inc. makes
Cool Baby, Inc. manufactures a freezer-based pacifier (teether) designed for infants to safely chew and reduce teething discomfort.
The freezer teether is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Freezer Teether Ref K002066
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cool Baby, Inc. have in the registry?
The registry currently lists 1 device for Cool Baby, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cool Baby, Inc.'s devices?
Among its 1 most recently registered device, Cool Baby, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cool Baby, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cool Baby, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cool Baby, Inc. in the registry?
The most recently registered devices listed for Cool Baby, Inc. include FREEZER TEETHER.