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510(k) K001347

MERIDIAN-II AND MERDIAN-PLUS by Meridian Co., Ltd. — Product Code GZO

K001347 is an FDA 510(k) premarket notification submitted by Meridian Co., Ltd. for the device "MERIDIAN-II AND MERDIAN-PLUS". The FDA issued a decision of Substantially Equivalent on November 3, 2000. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540. Meridian Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2000
Date Received
April 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Galvanic Skin Response Measurement
Device Class
Class II
Regulation Number
882.1540
Review Panel
NE
Submission Type

Other clearances by Meridian Co., Ltd.

  • K102375 — LUCIA (February 25, 2011)
  • K081962 — LAPEX BCS (December 29, 2008)
  • K034009 — LAPEX 2000 (January 21, 2005)
  • K023238 — MCPULSE (February 19, 2003)
  • K020360 — ABR-2000 (August 29, 2002)
  • K010897 — MERIDIAN-PORTABLE (June 19, 2001)

Other clearances for product code GZO

  • K150804 — QBioScan (October 19, 2015)
  • K152216 — SudoC (September 24, 2015)
  • K141872 — SUDOSCAN (November 21, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K111308 — ZYTO HAND CRADLE (August 30, 2011)
  • K102166 — ELECTRO INTERSTITIAL SCAN (December 10, 2010)
  • K100233 — SUDOSCAN (June 14, 2010)
  • K053004 — MSAS-VANTAGE (January 13, 2006)
  • K032935 — EPI-SCAN, MODEL P 100 (November 20, 2003)
  • K023355 — ASYRA (June 24, 2003)

FDA data resources