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FDA 510(k) Application Details - K062278
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K062278
Device Name
System,Network And Communication,Physiological Monitors
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
PO BOX 7018
ISSAQUAH, WA 98027-7018 US
Other 510(k) Applications for this Company
Contact
DAVID J GERAGHTY
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/07/2006
Decision Date
09/19/2006
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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