Eav COMBI-2

FDA 510(k) K020565 · Vibrant Health

Substantially Equivalent

510(k) numberK020565

Submission

Device name
Eav COMBI-2
Applicant
Vibrant Health
Beoeil, Quebec, CA
Received
February 20, 2002
Decision date
April 30, 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
K020567Akuport M1GZO · Traditional 05/02/2002SE
K020568Akuport M-2GZO · Traditional 04/30/2002SE

Questions and answers

When was Eav COMBI-2 cleared by the FDA?

Eav COMBI-2 (K020565) received a 510(k) decision of Substantially Equivalent on April 30, 2002, 69 days after the submission was received.

What is the product code of K020565?

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