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FDA 510(k) Application Details - K101639
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K101639
Device Name
Detector And Alarm, Arrhythmia
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
555 ZANG STREET
SUITE 100
LAKEWOOD, CO 80228 US
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Contact
CLAY ANSELMO
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
06/10/2010
Decision Date
06/25/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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