Papricalab
South KoreaFDA applicant, unverified
- Devices
- 1
What Papricalab makes
Papricalab manufactures the BinkieRT, a medical device designed for real-time monitoring of respiratory patterns in pediatric patients, particularly those with obstructive sleep apnea or other breathing disorders.
The BinkieRT is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
BinkieRT Ref K231852
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Papricalab have in the registry?
The registry currently lists 1 device for Papricalab. Devices recorded under merged duplicate company entries are counted once.
Which registries list Papricalab's devices?
Among its 1 most recently registered device, Papricalab has devices listed in FDA 510(k) (1 device).
What risk classes do Papricalab's devices fall under?
Among its 1 most recently registered device, the classes recorded for Papricalab's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Papricalab in the registry?
The most recently registered devices listed for Papricalab include BinkieRT.