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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrocardiograph
510(k) Number K083677
Device Name PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
Applicant
COMMWELL LTD.
555 THIRTEENTH ST., NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN KAHAN
Correspondent
COMMWELL LTD.
555 THIRTEENTH ST., NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN KAHAN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/11/2008
Decision Date 03/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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