Montrose Phototherapy Supply
Country not established
- Devices
- 2
What Montrose Phototherapy Supply makes
Montrose Phototherapy Supply manufactures infant phototherapy masks and phototherapy lights designed for neonatal jaundice treatment. These devices are intended for use in hospitals and clinical settings to safely administer controlled light therapy to newborns.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. The portfolio is listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
Infant Phototherapy Mask Ref K813214
Regimes: 510(k) Registry: 510(k)Infant Phototherapy Light Ref K813188
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Montrose Phototherapy Supply have in the registry?
The registry currently lists 2 devices for Montrose Phototherapy Supply. Devices recorded under merged duplicate company entries are counted once.
Which registries list Montrose Phototherapy Supply's devices?
Among its 2 most recently registered devices, Montrose Phototherapy Supply has devices listed in FDA 510(k) (2 devices).
What risk classes do Montrose Phototherapy Supply's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Montrose Phototherapy Supply's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Montrose Phototherapy Supply in the registry?
The most recently registered devices listed for Montrose Phototherapy Supply include INFANT PHOTOTHERAPY MASK and INFANT PHOTOTHERAPY LIGHT.