Breathe Me, Ltd.
IsraelFDA 510(k) applicant, unverified
- Devices
- 1
What Breathe Me, Ltd. makes
Breathe Me, Ltd. manufactures Peak.me, a digital respiratory health monitoring device designed to track and analyze breathing patterns for diagnostic and management purposes.
The company’s portfolio is regulated under FDA’s Class II device classification, with Peak.me authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Peak.me Ref K180487
510(k) 510(k)
Frequently asked questions
How many devices does Breathe Me, Ltd. have in the registry?
The registry currently lists 1 device for Breathe Me, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breathe Me, Ltd.'s devices?
Among its 1 most recently registered device, Breathe Me, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Breathe Me, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Breathe Me, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Breathe Me, Ltd. in the registry?
The most recently registered devices listed for Breathe Me, Ltd. include Peak.me.