Eav Kindling 2000S GSR Device

FDA 510(k) K020564 · Virbrant Health

Substantially Equivalent

510(k) numberK020564

Submission

Device name
Eav Kindling 2000S GSR Device
Applicant
Virbrant 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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Questions and answers

When was Eav Kindling 2000S GSR Device cleared by the FDA?

Eav Kindling 2000S GSR Device (K020564) 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 K020564?

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