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FDA 510(k) Application Details - K021376
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K021376
Device Name
Detector And Alarm, Arrhythmia
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
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Contact
JOEL C KENT
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
DSI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2002
Decision Date
07/24/2002
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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