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510(k) K192385

Device
IvWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
Applicant
IvWatch, LLC
510(k) number
K192385
Product code
PMS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-02
Date received
2019-09-03
Regulation
880.5725
Classification name
Peripheral Intravenous (piv) Infiltration Monitor
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Holly Novak
Address
630 Hofstadter Rd., Suite 300 Newport News VA US 23606 23606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PMS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233881ivWatch® Model 400Ivwatch, LLC2024-03-15
K222212ivWatch Model 400Ivwatch, LLC2022-08-24
K162478ivWatchIvwatch, LLC2016-12-22
K153605ivWatch Model 400Ivwatch, LLC2016-02-11

Legacy Summary#

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FDA Review#

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