Identifiers
- 510(k) Number
- K860249 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Holter Reporter is an electrocardiograph, a device used in the medical specialty of cardiovascular care. It is classified as a device class 2. The device is used to report on heart activity.
The Holter Reporter is supplied by Applied Cardiac Systems and has FDA 510K authorization. It has a product code of DPS and was cleared on March 11, 1986. The device is substantially equivalent to other devices in its class.
Frequently asked questions
What is the Holter Reporter used for?
The Holter Reporter is an electrocardiograph designed for cardiovascular care. Its primary function is to report on heart activity, serving as a diagnostic tool for monitoring cardiac function.
Who manufactures the Holter Reporter?
The Holter Reporter is manufactured by Applied Cardiac Systems, a company based in Laguna Hills, California. The device is supplied directly by this manufacturer.
What is the regulatory status of this device?
The Holter Reporter has FDA 510K authorization, specifically under K-number K860249. It was cleared on March 11, 1986, and is classified as a substantially equivalent device in class 2.
Is this device single-use or reusable?
The device data does not specify whether the Holter Reporter is single-use or reusable. This information would typically be found in the product labeling or user manual, which is not included in the provided specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: THE HOLTER REPORTER (TM) (K860249) — FDA 510 (k) | Innolitics, THE HOLTER REPORTER (TM) 510 (k) K860249 - FDA.report, 510(k) K860249 — THE HOLTER REPORTER (TM) - RegDataLab, Applied Cardiac Systems, Inc. FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860249 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Cardiac Systems
Sources (1)
- FDA 510(k) K860249 24 fields · synced Sep 23, 2026