Models 78504A & 78508A Patient Mon. Sys

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K821368 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Luer Lock Skirt

  Class II

  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

  Class II

  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

  Class II

  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

  Class II

  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

  Class I

  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

  Class II

  FDA 510(k) K781360 Active Cleared 7 Sep 1978

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