Denovo Proucts, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Denovo Proucts, LLC makes
Denovo Products, LLC manufactures the NEO NEST, a Class I medical device designed for neonatal care, likely intended for infant respiratory or thermal support in hospital settings.
The NEO NEST is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Denovo Teddy Gel Infant Heel Warmer Ref K103549
Regimes: 510(k) Registry: 510(k)Neo Nest Ref K112547
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Denovo Proucts, LLC have in the registry?
The registry currently lists 2 devices for Denovo Proucts, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denovo Proucts, LLC's devices?
Among its 2 most recently registered devices, Denovo Proucts, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Denovo Proucts, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Denovo Proucts, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Denovo Proucts, LLC in the registry?
The most recently registered devices listed for Denovo Proucts, LLC include DENOVO TEDDY GEL INFANT HEEL WARMER and NEO NEST.