Harpell Assoc., Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Harpell Assoc., Inc. makes
Harpell Assoc., Inc. manufactures the SPECTURN (Model TTK-128), a device designed for spectral analysis or imaging applications in medical diagnostics.
The SPECTURN (Model TTK-128) is classified as a Class I medical device under FDA regulations and is listed via a 510(k) pathway. The company is based in the United States.
Catalogue
Specturn, Model Ttk-128 Ref K923180
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Harpell Assoc., Inc. have in the registry?
The registry currently lists 1 device for Harpell Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harpell Assoc., Inc.'s devices?
Among its 1 most recently registered device, Harpell Assoc., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Harpell Assoc., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Harpell Assoc., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Harpell Assoc., Inc. in the registry?
The most recently registered devices listed for Harpell Assoc., Inc. include SPECTURN, MODEL TTK-128.