Skip to content

CC-201 ECG Monitoring Systems

by Anthro-Metrics Corp.

510(k) K813287

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 NumberK813287 Date14 Dec 1981ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.1025
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 CC-201 ECG Monitoring Systems is classified as a Detector and Alarm for Arrhythmia, designed to monitor and alert for cardiac arrhythmias. This device continuously records and displays electrocardiogram (ECG) signals to detect abnormal heart rhythms, aiding in clinical assessment and patient management.

Intended for use in clinical settings, the CC-201 ECG Monitoring Systems is a reusable device as indicated by its regulatory submission. It operates under FDA authorization via a 510(k) clearance (K813287) under regulation 870.1025, classified as a Class II medical device. No specific sterility or MRI safety details are provided in the data, and its supply and storage conditions are not explicitly stated.

Other devices from Anthro-Metrics Corp.

  • Cc-100

    Class II

  • Cc-103

    Class II

  • CC101 ECG Monitoring System

    Class II

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 CC-201 ECG Monitoring Systems serve in a healthcare setting?

    The CC-201 ECG Monitoring Systems is designed to continuously record and display electrocardiogram (ECG) signals, allowing clinicians to monitor and detect abnormal heart rhythms, such as arrhythmias. This aids in real-time clinical assessment and patient management by providing alerts when irregularities are identified.

  • Is the CC-201 ECG Monitoring Systems intended for single-use or reusable applications?

    The CC-201 ECG Monitoring Systems is classified as a reusable device, as indicated by its regulatory submission. This means it is designed for repeated use in clinical settings, though proper cleaning, maintenance, and sterilization procedures must be followed to ensure safety and functionality.

  • What regulatory pathway was followed for the CC-201 ECG Monitoring Systems, and what does this imply for its use?

    The CC-201 ECG Monitoring Systems received FDA authorization through a 510(k) clearance (K813287) under regulation 870.1025, classified as a Class II medical device. This implies it was determined to be substantially equivalent to a legally marketed device and meets FDA safety and performance standards for use as a Detector and Alarm for Arrhythmia in clinical environments.

  • Are there any specific storage or handling instructions provided for the CC-201 ECG Monitoring Systems?

    The provided data does not explicitly detail storage or handling conditions for the CC-201 ECG Monitoring Systems. 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 longevity.