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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Intravenous (Piv) Infiltration Monitor
510(k) Number K162478
Device Name ivWatch
Applicant
Ivwatch, LLC
1100 Exploration Way, Suite 209
Hampton,  VA  23666
Applicant Contact Jaclyn Lautz
Correspondent
Ivwatch, LLC
1100 Exploration Way, Suite 209
Hampton,  VA  23666
Correspondent Contact Jaclyn Lautz
Regulation Number880.5725
Classification Product Code
PMS  
Date Received09/06/2016
Decision Date 12/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Clinical Trials NCT02553421
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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