Rocky Mountain Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Rocky Mountain Medical Corp. makes
Rocky Mountain Medical Corp. manufactures medical devices for neonatal care, including phototherapy units for treating jaundice in infants, ambient light meters and dosimeters to monitor nursery lighting exposure, and incontinence aids for pediatric use. The company also produces infant thermometers and accessories like ambient light intensity reducers for nurseries, as well as surgical and procedural tools such as exchange trays and chucks.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Baby Light Dosimeter Ref K832298
Regimes: 510(k) Registry: 510(k)Nursery Ambient Light Meter Ref K860120
Regimes: 510(k) Registry: 510(k)Omni Infant Phototherapy Unit Ref K834430
Regimes: 510(k) Registry: 510(k)Prefer Incontinence Aid Ref K851876
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Tele-Temp Thermometer Ref K890202
Regimes: 510(k) Registry: 510(k)Baby Light Meter Ref K837494
Regimes: 510(k) Registry: 510(k)Alpha Chuck Ref K853970
Regimes: 510(k) Registry: 510(k)Isovol-Exchange Tray Ref K852167
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rocky Mountain Medical Corp. have in the registry?
The registry currently lists 9 devices for Rocky Mountain Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rocky Mountain Medical Corp.'s devices?
Among its 9 most recently registered devices, Rocky Mountain Medical Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Rocky Mountain Medical Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Rocky Mountain Medical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rocky Mountain Medical Corp. in the registry?
The most recently registered devices listed for Rocky Mountain Medical Corp. include BABY LIGHT DOSIMETER, NURSERY AMBIENT LIGHT METER, OMNI INFANT PHOTOTHERAPY UNIT and PREFER INCONTINENCE AID.