Reflectance Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Reflectance Medical, Inc. makes
Reflectance Medical, Inc. manufactures pulse oximeters designed for non-invasive monitoring of blood oxygen saturation (SpO₂) and heart rate. Their devices include standalone oximeters and multi-parameter models integrated with tablets for enhanced clinical data collection. Some models are portable, enabling use in mobile or home-care settings, while others are configured for stationary patient monitoring.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database. Reflectance Medical, Inc. is headquartered in the United States.
Catalogue
Mobile Careguide 2100 Oximeter Ref K122645
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Careguide Oximeter Ref K113656
Regimes: 510(k) Registry: 510(k)Multi-Parameter Mobile Careguide 4100 Oximeter Ref K141496
Regimes: 510(k) Registry: 510(k)Multi-Parameter Mobile Careguide 3100 Oximeter Ref K130079
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Reflectance Medical, Inc. have in the registry?
The registry currently lists 5 devices for Reflectance Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reflectance Medical, Inc.'s devices?
Among its 5 most recently registered devices, Reflectance Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Reflectance Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Reflectance Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Reflectance Medical, Inc. in the registry?
The most recently registered devices listed for Reflectance Medical, Inc. include MOBILE CAREGUIDE 2100 OXIMETER, MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET, CAREGUIDE OXIMETER and MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER.