FDA 510(k) Application Details - K062278

Device Classification Name System,Network And Communication,Physiological Monitors

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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
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Contact DAVID J GERAGHTY
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Regulation Number 870.2300

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Classification Product Code MSX
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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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