Draeger Medical Infant Care, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Draeger Medical Infant Care, Inc. makes
Draeger Medical Infant Care, Inc. manufactures medical devices for neonatal care, including a jaundice meter (Model JM 103) for measuring bilirubin levels in infants and a VersaLet 7700 Care Center, a transport and monitoring system for newborns requiring intensive care.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The portfolio is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Jaundice Meter, Model Jm 103 Ref K042522
Regimes: 510(k) Registry: 510(k)Versalet 7700 Care Center Ref K053399
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Draeger Medical Infant Care, Inc. have in the registry?
The registry currently lists 2 devices for Draeger Medical Infant Care, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Draeger Medical Infant Care, Inc.'s devices?
Among its 2 most recently registered devices, Draeger Medical Infant Care, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Draeger Medical Infant Care, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Draeger Medical Infant Care, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Draeger Medical Infant Care, Inc. in the registry?
The most recently registered devices listed for Draeger Medical Infant Care, Inc. include JAUNDICE METER, MODEL JM 103 and VERSALET 7700 CARE CENTER.