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510(k) K153605

ivWatch Model 400 by Ivwatch, LLC — Product Code PMS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 11, 2016
Date Received: December 17, 2015
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Peripheral Intravenous (Piv) Infiltration Monitor
Device Class: Class II
Regulation Number: 880.5725
Review Panel: HO
Submission Type

Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.