Criterion II Pacing System Monitors

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802325 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Samm

  Class II

  FDA 510(k) K820828 Active Cleared 14 Apr 1982

• Criterion II Pacing System Monitors

  Class II

  FDA 510(k) K800286 Active Cleared 12 Mar 1980

• Ekg Monitors, Various Models

  Class II

  FDA 510(k) K820986 Active Cleared 29 Apr 1982

• Ekg Telephone Converter

  Class II

  FDA 510(k) K820904 Active Cleared 21 Apr 1982

• Criterion II Rhythm Profile Monitor

  Class II

  FDA 510(k) K803315 Active Cleared 22 Jan 1981

• The Criterion II Pacing Sys. Monitor

  Class II

  FDA 510(k) K802782 Active Cleared 19 Nov 1980