Am Labs, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Am Labs, Inc. makes
Am Labs, Inc. manufactures ultraviolet sunlamps and the Sinuson 810 ultrasound scanner, a diagnostic imaging device used for sinus cavity visualization.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Sunlamp Ref K803264
Regimes: 510(k) Registry: 510(k)Sinuson 810 Ultrasound Scanner Ref K827663
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Am Labs, Inc. have in the registry?
The registry currently lists 2 devices for Am Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Am Labs, Inc.'s devices?
Among its 2 most recently registered devices, Am Labs, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Am Labs, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Am Labs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Am Labs, Inc. in the registry?
The most recently registered devices listed for Am Labs, Inc. include SUNLAMP and SINUSON 810 ULTRASOUND SCANNER.