IvWatch Model 400

Peripheral Intravenous (piv) Infiltration Monitor

IvWatch, LLC

The following data is part of a premarket notification filed by Ivwatch, Llc with the FDA for Ivwatch Model 400.

Pre-market Notification Details

Device IDK222212
510k NumberK222212
Device Name:IvWatch Model 400
ClassificationPeripheral Intravenous (piv) Infiltration Monitor
Applicant ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News,  VA  23606
ContactHolly Novak
CorrespondentHolly Novak
ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News,  VA  23606
Product CodePMS  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-25
Decision Date2022-08-24

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