Dantec Counterpoint MK2(TM)

FDA 510(k) K913957 · Dantec Medical, Inc.

Substantially Equivalent

510(k) numberK913957

Submission

Device name
Dantec Counterpoint MK2(TM)
Applicant
Dantec Medical, Inc.
Washington, DC, US
Received
September 4, 1991
Decision date
January 30, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWJ – Stimulator, Auditory, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1900
Specialty
Neurology

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Questions and answers

When was Dantec Counterpoint MK2(TM) cleared by the FDA?

Dantec Counterpoint MK2(TM) (K913957) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 148 days after the submission was received.

What is the product code of K913957?

The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.