Calysto Series IV Patient Care Monitors and Central Station and ECG Management System

• • Terminated Z-0305-06 FDA Unclassified (pre-2012) ·initiated 16 Sep 2005

  Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.

510(k) Number

K033030 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Witt Biomedical Series II-Ep

  Class II

  FDA 510(k) K923054 Active Cleared 25 Feb 1993

• Calysto Series IV Physio-Monitoring and Information System

  Class II

  FDA 510(k) K063547 Active Cleared 21 Dec 2006

• Witt Biomedical Vx-80

  Class II

  FDA 510(k) K880258 Active Cleared 16 Jun 1988

• Image IV DICOM Image Archival PACS Network

  Class II

  FDA 510(k) K010058 Active Cleared 21 Mar 2001

• Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units

  Class II

  FDA 510(k) K973474 Active Cleared 13 Mar 1998

• Witt Biomedical Image III

  Class II

  FDA 510(k) K945582 Active Cleared 19 Jun 1995

See all devices from Witt Biomedical Corp →