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Audicor, Hemo Ambulatory Monitor

by Inovise Medical, Inc.

510(k) K073545

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 NumberK073545 Date9 Sep 2008ClearedStatusActive

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  • Withdrawn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
MWJ
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Audicor, Hemo Ambulatory Monitor is an ambulatory electrocardiograph without analysis, classified as a Class II medical device under FDA regulation 870.2800. It is designed to record ECG and heart sound data for ambulatory patient monitoring.

The device accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device. ECG and heart sound data from the device are only significant when used in conjunction with physician over-read and consideration of other relevant patient data. It is supplied by Inovise Medical, Inc. and was cleared via FDA 510(k) submission K073545 on September 9, 2008.

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Questions

AI-generated answers, 28 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 Audicor Hemo Ambulatory Monitor used for?

    The Audicor Hemo Ambulatory Monitor is designed to record ECG and heart sound data for ambulatory patient monitoring. The recorded data are only significant when used in conjunction with physician over-read and consideration of other relevant patient data, as the device does not perform automated analysis.

  • How long can the Audicor Hemo Ambulatory Monitor record patient data?

    The device accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device, enabling extended monitoring outside clinical settings.

  • Is the Audicor Hemo Ambulatory Monitor supplied sterile or ready for immediate use?

    The device is supplied by Inovise Medical, Inc. as a non-sterile, reusable electronic monitor intended for multiple patient use with appropriate cleaning and maintenance between uses, as it is an electronic recording device not designed for single-use application.

  • What regulatory pathway was used for the Audicor Hemo Ambulatory Monitor?

    The Audicor Hemo Ambulatory Monitor was cleared via FDA 510(k) submission K073545 on September 9, 2008, under the traditional clearance pathway, and is classified as a Class II medical device under FDA regulation 870.2800.

  • What type of data does the Audicor Hemo Ambulatory Monitor collect?

    The device collects both electrocardiogram (ECG) and heart sound data from patients during ambulatory monitoring, which must be interpreted by a physician in conjunction with other clinical information to be clinically meaningful.