Carnation Ambulatory Monitor (CAM)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210036 FDA 510(k)
- FDA Product Code
- DSH 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 Carnation Ambulatory Monitor (CAM) is a magnetic tape recorder classified as a Class II medical device under the Cardiovascular specialty. It is designed for the recording of physiological signals in an ambulatory setting.
The device received FDA 510(k) clearance (K210036) on February 5, 2021, and is substantially equivalent to a predicate device. It is manufactured by Bardy Diagnostics, Inc. in Seattle, Washington, and is intended for use in cardiovascular monitoring applications.
Frequently asked questions
What is the Carnation Ambulatory Monitor (CAM) used for?
The Carnation Ambulatory Monitor (CAM) is designed for the recording of physiological signals in an ambulatory setting, specifically intended for cardiovascular monitoring applications as stated in its device description.
How is the Carnation Ambulatory Monitor (CAM) supplied and is it reusable?
The device is a magnetic tape recorder, which implies it uses physical tape media for signal storage; however, the provided data does not specify whether the tape is single-use or reusable, nor does it detail the supply configuration such as kit contents or packaging.
What regulatory pathway was used for the Carnation Ambulatory Monitor (CAM)?
The Carnation Ambulatory Monitor (CAM) received FDA 510(k) clearance (K210036) on February 5, 2021, and was determined to be substantially equivalent to a predicate device under the Class II classification for cardiovascular devices.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210036 | Class II | Active |
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Manufacturer
- Manufacturer
- Bardy Diagnostics, Inc.
Sources (1)
- FDA 510(k) K210036 24 fields · synced Oct 6, 2026