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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K071802
Device Name TESLA GUARD, MODEL EFT G04
Applicant
Mammendorfer Institut Fur Physik Und Medizin GmbH
13605 W. 7th Ave.
Golden,  CO  80401
Applicant Contact ROBERT N CLARK
Correspondent
Mammendorfer Institut Fur Physik Und Medizin GmbH
13605 W. 7th Ave.
Golden,  CO  80401
Correspondent Contact ROBERT N CLARK
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/02/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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