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FDA 510(k) Application Details - K050175
Device Classification Name
Detector And Alarm, Arrhythmia
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510(K) Number
K050175
Device Name
Detector And Alarm, Arrhythmia
Applicant
SPACELABS MEDICAL, INC.
5150 220TH AVE SE
P.O. BOX 7018
ISSAQUAH, WA 98027-7018 US
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Contact
AL VAN HOUDT
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
01/26/2005
Decision Date
03/04/2005
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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