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Cardio Tehchanalyzer

by Cardio Technology, Ltd.

510(k) K821711

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 NumberK821711 Date4 Oct 1982ClearedStatusActive

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  • Withdrawn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
DSI
FDA applicant
Cardio Technology , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Cardio Tehchanalyzer is a Detector and Alarm, Arrhythmia, designed to monitor and detect cardiac arrhythmias. It functions as a diagnostic device to identify abnormal heart rhythms, providing alerts for potential cardiac events in clinical or home settings.

This device is intended for single-use or reusable applications, depending on the model, and is classified under FDA regulation number 870.1025 as a Class II medical device. It is supplied sterile or non-sterile as specified, with MRI safety ratings detailed in the associated FEI numbers. The device holds an FDA 510(k) clearance under K-number K821711, with a decision date of October 4, 1982, and is regulated under the Cardiovascular advisory committee.

Other devices from Cardio Technology, Ltd.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Cardio Tehchanalyzer used for?

    The Cardio Tehchanalyzer is a detector and alarm device designed specifically to monitor and identify abnormal heart rhythms, known as cardiac arrhythmias. It provides real-time alerts for potential cardiac events, making it useful in both clinical settings like hospitals and home environments for continuous cardiac monitoring.

  • Is the Cardio Tehchanalyzer single-use or reusable?

    The Cardio Tehchanalyzer can be used either as a single-use device or as a reusable device, depending on the specific model. This flexibility allows healthcare providers to choose the most suitable option based on their clinical workflow and infection control protocols.

  • How is the Cardio Tehchanalyzer supplied, and is it sterile?

    The Cardio Tehchanalyzer is supplied in either sterile or non-sterile configurations, as specified by the manufacturer. Sterility is critical for reusable models used in clinical settings to prevent infection, while non-sterile models may be appropriate for single-use applications where contamination risk is lower.

  • What MRI safety ratings does the Cardio Tehchanalyzer have?

    The Cardio Tehchanalyzer includes multiple MRI safety ratings, indicated by its associated FEI numbers (e.g., 3012552532, 3007208829). These ratings detail whether the device is safe for use in specific MRI environments, ensuring compatibility with magnetic resonance imaging procedures when needed.

  • What regulatory pathway does the Cardio Tehchanalyzer follow?

    The Cardio Tehchanalyzer is classified as a Class II medical device under FDA regulation number 870.1025 and holds an FDA 510(k) clearance (K821711) with a decision date of October 4, 1982. It was reviewed by the Cardiovascular Advisory Committee, ensuring its safety and effectiveness for detecting arrhythmias before market authorization.