Meridian-Portable

FDA 510(k) K010897 · Meridian Co., Ltd.

Substantially Equivalent

510(k) numberK010897

Submission

Device name
Meridian-Portable
Applicant
Meridian Co., Ltd.
Songpa-Gu, Seoul, KR
Received
March 26, 2001
Decision date
June 19, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Meridian-Portable cleared by the FDA?

Meridian-Portable (K010897) received a 510(k) decision of Substantially Equivalent on June 19, 2001, 85 days after the submission was received.

What is the product code of K010897?

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