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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 K233881
Device Name ivWatch® Model 400
Applicant
Ivwatch, LLC
700 Tech Center Pkwy.
Suite 300
Newport News,  VA  23606
Applicant Contact Holly Novak
Correspondent
Ivwatch, LLC
700 Tech Center Pkwy.
Suite 300
Newport News,  VA  23606
Correspondent Contact Holly Novak
Regulation Number880.5725
Classification Product Code
PMS  
Date Received12/08/2023
Decision Date 03/15/2024
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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