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510(k) K192385

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable by Ivwatch, LLC — Product Code PMS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 2, 2020
Date Received: September 3, 2019
Clearance Type: Traditional
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.