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# Bardy Diagnostic 14-day P-wave Monitor Cleared
- URL: https://www.fdaweb.com/bardy-diagnostic-14-day-p-wave-monitor-cleared/
- Published: 2019-09-06T12:00:00.000Z
- Updated: 2026-09-15T01:48:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144941

FDA has cleared a Bardy Diagnostics 510(k) for its 14-day version of the Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. The device is an extension of the company’s previously cleared two-day and seven-day CAM product lines. It detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is important for accurate arrhythmia diagnosis and patient management, the company says.