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510(k) K010897

MERIDIAN-PORTABLE by Meridian Co., Ltd. — Product Code GZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2001
Date Received
March 26, 2001
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

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  • K020360 — ABR-2000 (August 29, 2002)
  • K001347 — MERIDIAN-II AND MERDIAN-PLUS (November 3, 2000)

Other clearances for product code GZO

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  • 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)