IvWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

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, Device Accessories: Extension Module, Smarttouch Sensor, Patient Cable.

Pre-market Notification Details

Device IDK192385
510k NumberK192385
Device Name:IvWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
ClassificationPeripheral Intravenous (piv) Infiltration Monitor
Applicant ivWatch, LLC 630 Hofstadter Road, Suite 300 Newport News,  VA  23606
ContactHolly Novak
CorrespondentHolly Novak
ivWatch, LLC 630 Hofstadter Road, Suite 300 Newport News,  VA  23606
Product CodePMS  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2020-07-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20814088020591 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
20814088020591 K192385 000
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00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
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20814088020591 K192385 000
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20814088020591 K192385 000
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00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
00814088020122 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
20814088020591 K192385 000
00814088020122 K192385 000
00814088020115 K192385 000
00814088020115 K192385 000

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