Question 1

What types of medical devices does AMBCO Electronics manufacture?

Accepted Answer

AMBCO Electronics specializes in audiometric devices, specifically tone audiometers. These include manual and automated versions, which generate pure-tone signals to assess hearing across various frequencies. These tools are primarily used in clinical and diagnostic audiology settings to evaluate auditory function.

Question 2

Where is AMBCO Electronics based?

Accepted Answer

AMBCO Electronics is headquartered in the United States. The company’s location is relevant for understanding its regulatory context, as it operates under U.S. medical device regulations.

Question 3

How are AMBCO Electronics’ devices classified by regulatory authorities?

Accepted Answer

AMBCO Electronics’ devices are classified as FDA Class II medical devices. This classification is determined by the U.S. Food and Drug Administration based on factors like risk level and intended use. Class II devices generally require special controls beyond general controls to ensure safety and effectiveness.

Question 4

Are AMBCO Electronics’ devices listed in any regulatory registries?

Accepted Answer

Yes, AMBCO Electronics’ devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, improving transparency and traceability in healthcare settings.

Device	Model / Reference	Registries	Class	Status
Ambco	2500	FDA UDI	Class II	Active
Ambco	650A	FDA UDI	Class II	Active
Ambco	1000+	FDA UDI	Class II	Active
Ambco	1000+P	FDA UDI	Class II	Active
Ambco	650AB	FDA UDI	Class II	Active

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