Telephone Link Data Transmission Sys

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K821478 ↗

FDA Product Code

HGM

Device Class

Class II

Regulation

21 CFR Part 884.2740

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Fetal Monitor Model FHM-1

  Class II

  FDA 510(k) K800013 Active Cleared 7 Mar 1980

• Non-Coring Huber Type Needles

  Class II

  FDA 510(k) K873957 Active Cleared 23 Oct 1987

• Central Display System #CS400

  Class II

  FDA 510(k) K821479 Active Cleared 25 Jun 1982

• Wall Mounted Laser Positioning Device

  Class I

  FDA 510(k) K801541 Active Cleared 20 Aug 1980

• Neonatal Physiological Monitor Model Pm 20

  Class II

  FDA 510(k) K863494 Active Cleared 22 Dec 1986

• Modification Fetal Monitor Model Fm-2

  Class II

  FDA 510(k) K852518 Active Cleared 5 Jul 1985

See all devices from Advantage Medical Systems, Inc. →