Amplaid USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Amplaid USA, Inc. makes
Amplaid USA, Inc. manufactures diagnostic systems for auditory and visual evoked potential testing, including portable audiometers (models 101, 151, 161) and evoked potential systems (e.g., EVOKED POTENTIALS SYSTEM MK10, AMPLAID MK15). Their portfolio also includes visual pattern reversal generators, photic stimulation systems, somatosensory stimulators, and self-recording admittance meters (e.g., model 709) for audiological assessments. The company produces equipment for electrophysiological testing and hearing evaluations, such as the MK6 ERA system.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. Their products are intended for use in clinical and diagnostic settings, adhering to U.S. medical device compliance standards. The manufacturer is based in the United States.
Catalogue
Evoked Potentials System MK10 Ref K832510
Regimes: 510(k) Registry: 510(k)Visual Pattern Reversal Gen. & Photic S. Ref K810481
Regimes: 510(k) Registry: 510(k)101, 151, 161 Portable Audiometers Ref K802963
Regimes: 510(k) Registry: 510(k)Amplaid MK15 (Evoked Potential System) Ref K861014
Regimes: 510(k) Registry: 510(k)Amplaid Mark 4 And Mark 5 Ref K781667
Regimes: 510(k) Registry: 510(k)Self-Recording Admittance Meter 709 Ref K802097
Regimes: 510(k) Registry: 510(k)Somatosensory Stimulator Ref K810482
Regimes: 510(k) Registry: 510(k)MK6 Era System Ref K810473
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amplaid USA, Inc. have in the registry?
The registry currently lists 8 devices for Amplaid USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amplaid USA, Inc.'s devices?
Among its 8 most recently registered devices, Amplaid USA, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Amplaid USA, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Amplaid USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amplaid USA, Inc. in the registry?
The most recently registered devices listed for Amplaid USA, Inc. include EVOKED POTENTIALS SYSTEM MK10, VISUAL PATTERN REVERSAL GEN. & PHOTIC S., 101, 151, 161 PORTABLE AUDIOMETERS and AMPLAID MK15 (EVOKED POTENTIAL SYSTEM).