Datacaptor

• • Terminated Z-2377-2012 FDA Class II ·initiated 10 Aug 2012

  Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron

• • Terminated Z-2403-2011 FDA Unclassified (pre-2012) ·initiated 25 Aug 2010

  Software: Data cached on the Neuron due to server unavailability is not being delivered to the server after server availability is restored. If a compact flash failure occurs, the file system may be corrupted and result in system hangs, lock-ups or crashes. Batteries can discharge completely in a Capsule Neuron" UMPC even though it is connected to power source

510(k) Number

K032142 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module

  Class II

  FDA 510(k) K171751 Active Cleared 24 Oct 2017

• Modification to Datacaptor

  Class II

  FDA 510(k) K020197 Active Cleared 21 Feb 2002

• Capsule Vitals Plus Patient Monitoring System

  Class II

  FDA 510(k) K210204 Active Cleared 19 Oct 2021

• SmartLinx Vitals Plus Patient Monitoring System

  Class II

  FDA 510(k) K183638 Active Cleared 17 Apr 2019

• DataCaptor

  Class II

  FDA 510(k) K013019 Active Cleared 18 Dec 2001

• SmartLinx Vitals Plus Patient Monitoring System

  Class II

  FDA 510(k) K180734 Active Cleared 8 Aug 2018

See all devices from Capsule Technologie →