FDA 510(k) Application Details - K052854

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K052854
Device Name System,Network And Communication,Physiological Monitors
Applicant MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
11811 WILLOWS RD., N.E.
REDMOND, WA 98052 US
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Contact TERESA DAVIDSON
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 10/11/2005
Decision Date 01/20/2006
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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