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FDA 510(k) Application Details - K162523
Device Classification Name
Hyperthermia Monitor
More FDA Info for this Device
510(K) Number
K162523
Device Name
Hyperthermia Monitor
Applicant
BRAIN COOL AB
SCHEELEVAGEN 2
MEDICON VILLAGE
MEDICON VILLAGE SE-223 81 SE
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Contact
MARTIN WALEIJ
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
09/09/2016
Decision Date
05/03/2017
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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