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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K142374
Device Name ivWatch Model 400
Applicant
Ivwatch, LLC
469 Mclaws Cir.
Williamsburg,  VA  23185
Applicant Contact Javier Garriz
Correspondent
Ivwatch, LLC
469 Mclaws Cir.
Williamsburg,  VA  23185
Correspondent Contact Javier Garriz
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received08/26/2014
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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