Massie Research Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Massie Research Laboratories, Inc. makes
Massie Research Laboratories, Inc. manufactures the RETCAM II, a retinal imaging device used for capturing high-resolution images of the retina, and the PATHFINDER, a handheld retinal imaging system designed for pediatric and neonatal patients.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Retcam Ii Ref K001275
Regimes: 510(k) Registry: 510(k)Pathfinder Ref K031788
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Massie Research Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Massie Research Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Massie Research Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Massie Research Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Massie Research Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Massie Research Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Massie Research Laboratories, Inc. in the registry?
The most recently registered devices listed for Massie Research Laboratories, Inc. include RETCAM II and PATHFINDER.