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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K112830
Device Name ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
Applicant
Noninvasive Medical Technologies, Inc.
6412 S. Arville St.
Las Vegas,  NV  89118
Applicant Contact MARC O'GRIOFA
Correspondent
Noninvasive Medical Technologies, Inc.
6412 S. Arville St.
Las Vegas,  NV  89118
Correspondent Contact MARC O'GRIOFA
Regulation Number870.2770
Classification Product Code
DSB  
Date Received09/28/2011
Decision Date 11/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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