ivWatch Model 400— 510(k) K153605

Substantially Equivalent

Ivwatch, LLC

FDA 510(k) clearance K153605 for ivWatch Model 400, Substantially Equivalent on 2016-02-11. 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: 2015-12-17
Decision date: 2016-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Williamsburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PMS

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

More clearances from Ivwatch, LLC

K142374 — ivWatch Model 4002015-02-13

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