Akuport M1

FDA 510(k) K020567 · Vibrant Health

Substantially Equivalent

510(k) numberK020567

Submission

Device name
Akuport M1
Applicant
Vibrant Health
Beoeil, Quebec, CA
Received
February 20, 2002
Decision date
May 2, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GZO – Device, Galvanic Skin Response Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1540
Specialty
Neurology

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More from Galloway Technologies, LLC

510(k)DeviceDecision
K020568Akuport M-2GZO · Traditional 04/30/2002SE
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Questions and answers

When was Akuport M1 cleared by the FDA?

Akuport M1 (K020567) received a 510(k) decision of Substantially Equivalent on May 2, 2002, 71 days after the submission was received.

What is the product code of K020567?

The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.