As 191 ECG Telemetry Module

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831429 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Porta Fib III

  Class II

  FDA 510(k) K822961 Active Cleared 1 Nov 1982

• Pilling Diamond Knife

  Class I

  FDA 510(k) K822749 Active Cleared 6 Oct 1982

• Infusion Pump Retrograde Exten. As 715

  Class II

  FDA 510(k) K830654 Active Cleared 24 Mar 1983

• Ti-1000 Transport Incubator

  Class II

  FDA 510(k) K831028 Active Cleared 9 May 1983

• PZ-800 Volume Ventilator

  Class II

  FDA 510(k) K822835 Active Cleared 29 Sep 1983

• As 700 Series Infusion Pump Admin.

  Class II

  FDA 510(k) K821377 Active Cleared 2 Jul 1982

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