Braemar Cardiokey Holter Recorder
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130294 FDA 510(k)
- FDA Product Code
- MWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2800 FDA 510(k)
- Regulation Number
- 870.2800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Braemar Cardiokey Holter Recorder is an ambulatory electrocardiograph device without analysis, designed to record physiological signals from amplifiers, signal conditioners, or computers. It is classified as a Class II medical device under FDA regulation 870.2800 and has been determined to be substantially equivalent to a predicate device.
The device is supplied as a Holter recorder system, model CK100, and is intended for use in ambulatory cardiac monitoring. It received FDA 510(k) clearance (K130294) on October 16, 2013, and is manufactured by Braemar Manufacturing, LLC in San Diego, California.
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: BRAEMAR CARDIOKEY HOLTER RECORDER (K130294) — FDA 510(k) | Innolitics, CardioKey - Philips Ambulatory Monitoring and Diagnostics, Cardiokey - Holter Recorder - BRAEMAR MANUFACTURING, LLC, PDF S10Ok) Summary Date: 02/04/2013 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130294 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Braemar Manufacturing, LLC
Sources (1)
- FDA 510(k) K130294 24 fields · synced Oct 1, 2026