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FDA 510(k) Application Details - K100071
Device Classification Name
Hyperthermia Monitor
More FDA Info for this Device
510(K) Number
K100071
Device Name
Hyperthermia Monitor
Applicant
EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG
BRUCKNERSTRASSE 6/7A
1040 WIEN
VIENNA 1040 AT
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Contact
MICHAEL KUEHLING
Other 510(k) Applications for this Contact
Regulation Number
870.5900
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Classification Product Code
NZE
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More FDA Info for this Product Code
Date Received
01/11/2010
Decision Date
10/12/2010
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
Y
Expedited Review
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