FDA 510(k) Application Details - K130339

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K130339
Device Name System,Network And Communication,Physiological Monitors
Applicant EXTENSION , INC
7250 SW 154TH TERRACE
BEAVERTON, OR 97007 US
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Contact TIM GEE
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 02/11/2013
Decision Date 07/11/2013
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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