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Minimon 7136B Patient Monitor

by Kontron, Inc.

510(k) K883109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883109 Date17 Jan 1989ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Minimon 7136B Patient Monitor is a Class II cardiac monitoring device designed to measure and display cardiac parameters. It functions as a cardiotachometer and rate alarm, providing real-time monitoring of heart rate and rhythm for clinical assessment in cardiovascular settings.

This device is intended for use in clinical environments, supplied as a reusable medical instrument. It is not specified as MRI-safe or single-use, and its regulatory status includes an FDA 510(k) clearance under the product code DRT, filed in 1989. The device adheres to the regulatory requirements outlined in 870.2300 and is categorized under the cardiovascular specialty.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the Minimon 7136B Patient Monitor serve in a healthcare setting?

    The Minimon 7136B Patient Monitor is designed to measure and display cardiac parameters, functioning as a cardiotachometer and rate alarm. It provides real-time monitoring of heart rate and rhythm, which is essential for clinical assessment in cardiovascular settings to help clinicians evaluate a patient’s cardiac status.

  • Is the Minimon 7136B Patient Monitor intended for single-use or reusable applications?

    The Minimon 7136B Patient Monitor is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance.

  • What regulatory pathway was followed for FDA clearance of the Minimon 7136B Patient Monitor?

    The Minimon 7136B Patient Monitor received FDA clearance through a traditional 510(k) process, filed under product code DRT in 1988 and cleared on January 17, 1989. It was determined to be substantially equivalent to a predicate device and falls under the cardiovascular specialty category.

  • Are there any specific storage or handling requirements mentioned for the Minimon 7136B Patient Monitor?

    The provided data does not specify storage or handling instructions for the Minimon 7136B Patient Monitor. However, as a reusable medical device, it should be stored in a clean, dry environment and maintained according to manufacturer guidelines to ensure proper functionality and hygiene.