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COMMANDER II

by Cardiocom

510(k) K043096

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 NumberK043096 Date24 Nov 2004ClearedStatusActive

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  • Withdrawn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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 COMMANDER II is a vital sign telemonitoring system designed to enable health care professionals to remotely monitor patients' vital signs. It is substantially equivalent to the Home Care Monitoring System, AvidCare Corp., K010029, and was cleared by the FDA under 510(k) K043096.

The device is supplied as a vital sign telemonitoring system with a screen and is intended for remote patient monitoring. It is a single-use device, and its storage and sterilization requirements are not specified in the provided data.

Other devices from Cardiocom, LLC

Questions

AI-generated answers, 23 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 is the COMMANDER II used for?

    The COMMANDER II is a vital sign telemonitoring system with a screen. It is intended for remote patient monitoring, enabling health care professionals to monitor patients' vital signs from a distance.

  • Is the COMMANDER II a single-use device?

    Yes, the COMMANDER II is a single-use device. The provided data does not specify any requirements for its reuse.

  • How is the COMMANDER II supplied?

    The device is supplied as a vital sign telemonitoring system with a screen. It is intended for remote patient monitoring.

  • What is the regulatory status of the COMMANDER II?

    The COMMANDER II was substantially equivalent to the Home Care Monitoring System, AvidCare Corp., K010029, and was cleared by the FDA under 510(k) K043096.