Cleared Special

AGILENT M2636A TELEMON MONITOR

K001436 · Agilent Technologies, Inc. · Cardiovascular
Jun 2000
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K001436 is an FDA 510(k) clearance for the AGILENT M2636A TELEMON MONITOR, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on June 7, 2000, 30 days after receiving the submission on May 8, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K001436 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2000
Decision Date June 07, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

Similar Devices — DSI Detector And Alarm, Arrhythmia

All 397
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · Boston Scientific Cardiac Diagnostic Technologies, Inc. · Jan 2026
MoMe ARC? Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356 · Infobionic, Inc. · Jul 2025
Zio AT? device (A100A1001)
K240177 · iRhythm Technologies, Inc. · Oct 2024
MoMe? ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · Infobionic, Inc. · Oct 2023
SmartCardia 7L Platform
K231276 · Smartcardia SA · Aug 2023
Unified Arrhythmia Diagnostic System PocketECG IV
K193104 · Medicalgorithmics S.A. · Apr 2020