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510(k) K083322

NEUROMETRIX BIOAMPLIFIER by Neurometrix, Inc. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2009
Date Received
November 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

Other clearances by Neurometrix, Inc.

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  • K140333 — ASCEND (July 3, 2014)
  • K130919 — SENSUS (July 2, 2013)
  • K121816 — SENSUS ELECTRODE (November 26, 2012)
  • K121184 — SENSUS (August 2, 2012)
  • K091155 — ASCEND (September 3, 2009)
  • K083818 — UNIVERSAL ELECTRODES (January 21, 2009)
  • K081871 — UNIVERSAL ELECTRODES (September 29, 2008)

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