Hi-Tech Laboratories, Inc.
Country not established
- Devices
- 1
What Hi-Tech Laboratories, Inc. makes
Hi-Tech Laboratories, Inc. manufactures the HI-TECH LAB Model Concha All-In-Ear, a custom-fitted hearing aid designed for in-the-ear placement. This device is intended for individuals requiring amplification solutions tailored to the contours of the ear canal.
The company’s portfolio is regulated under Class I medical devices in the United States, with the HI-TECH LAB Model Concha All-In-Ear listed via the FDA’s 510(k) pathway. The manufacturer operates from the US.
Catalogue
Hi-Tech Lab Model Concha All In Ear Ref K853967
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hi-Tech Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Hi-Tech Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hi-Tech Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Hi-Tech Laboratories, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Hi-Tech Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hi-Tech Laboratories, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hi-Tech Laboratories, Inc. in the registry?
The most recently registered devices listed for Hi-Tech Laboratories, Inc. include HI-TECH LAB MODEL CONCHA ALL IN EAR.