Collins Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Collins Medical, Inc. makes
Collins Medical, Inc. manufactures respiratory diagnostic devices, including infant and pediatric plethysmographs for lung function testing in young patients. Their portfolio also includes gas exchange monitors (GEM), such as models for neonatal and pediatric use, as well as a pediatric lung function system (HAWK, EAGLE). Additionally, they produce a pediatric lung function testing system (Collins CPL).
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Gem, Model 004110 Ref K030464
Regimes: 510(k) Registry: 510(k)Gem; Hawk; Eagle; Models 004110, 0044120, 004130 Ref K030917
Regimes: 510(k) Registry: 510(k)Collins Cpl Ref K992743
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Collins Medical, Inc. have in the registry?
The registry currently lists 4 devices for Collins Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Collins Medical, Inc.'s devices?
Among its 4 most recently registered devices, Collins Medical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Collins Medical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Collins Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Collins Medical, Inc. in the registry?
The most recently registered devices listed for Collins Medical, Inc. include INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400, GEM, MODEL 004110, GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 and COLLINS CPL.