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FDA 510(k) Application Details - K082013
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K082013
Device Name
Electrocardiograph
Applicant
TELOVITAL GMBH TELEMEDIZIN
901 KING ST., SUITE 200
ALEXANDRIA, VA 22314 US
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Contact
Calley Herzog
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2008
Decision Date
11/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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