FDA 510(k) Application Details - K143152

Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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510(K) Number K143152
Device Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant LD TECHNOLOGY LLC
100 N. Biscayne Blvd., Suite 502
Miami, FL 33132 US
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Contact Albert Maarek
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Regulation Number 870.2780

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Classification Product Code JOM
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Date Received 11/03/2014
Decision Date 07/22/2015
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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