ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable— 510(k) K192385

Name: FDA 510(k) clearance K192385
Creator: U.S. Food and Drug Administration
Published: 2020-07-02

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K192385 for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable, Substantially Equivalent on 2020-07-02. Applicant: Ivwatch, LLC. Device class: 2.

Clearance details

Applicant: Ivwatch, LLC
Product code: Code PMS
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2019-09-03
Decision date: 2020-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport News, VA, US

Download summary PDF View on FDA.gov ↗

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K233881 — ivWatch® Model 4002024-03-15
K222212 — ivWatch Model 4002022-08-24
K162478 — ivWatch2016-12-22
K153605 — ivWatch Model 4002016-02-11

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