ivWatch Model 400— 510(k) K142374

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K142374 for ivWatch Model 400, Substantially Equivalent on 2015-02-13. Applicant: Ivwatch, LLC. Device class: 2.

Clearance details

Applicant: Ivwatch, LLC
Product code: Code MRZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2014-08-26
Decision date: 2015-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ivwatch, LLC

K233881 — ivWatch® Model 4002024-03-15
K222212 — ivWatch Model 4002022-08-24
K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable2020-07-02
K162478 — ivWatch2016-12-22
K153605 — ivWatch Model 4002016-02-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.