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510(k) K103791

PHYSIOGLOVE ES WITH ECG ANALYSIS by Commwell , Ltd. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2011
Date Received
December 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Commwell , Ltd.

  • K083677 — PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 (March 10, 2009)
  • K050674 — PHYSIOGLOVE ES (April 25, 2006)

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