Carnation Ambulatory Monitor
FDA 510(k) K192556 · Bardy Diagnostics, Inc.
510(k) numberK192556
Submission
- Device name
- Carnation Ambulatory Monitor
- Applicant
- Bardy Diagnostics, Inc.
Seattle, WA, US - Received
- September 17, 2019
- Decision date
- October 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K260157 | LifeLens Physiological MonitorDSH · Traditional | LifeLens Technologies, Inc. | 07/09/2026SE |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)DSH · Traditional | Smwmed, Inc. | 04/23/2026SE |
| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | Vitalograph , Ltd. | 12/03/2025SE |
| K243650 | Zio® monitor (DFG0001)DSH · Traditional | iRhythm Technologies, Inc. | 08/15/2025SE |
| K243603 | AeviceMDDSH · Traditional | Aevice Health Pte. , Ltd. | 05/05/2025SE |
| K242583 | AT-Patch (ATP-C130/ATP-C70)DSH · Traditional | Atsens Co., Ltd. | 05/02/2025SE |
| K232670 | HiCardi+ H100DSH · Traditional | MEZOO Co., Ltd. | 09/20/2024SE |
| K233906 | S-Patch (S-Patch ExL)DSH · Special | Wellysis Corp. | 02/16/2024SE |
| K231104 | ABPMproDSH · Traditional | Somnomedics GmbH | 11/27/2023SE |
| K233110 | Carnation Ambulatory MonitorDSH · Traditional | Bardy Diagnostics, Inc. | 11/22/2023SE |
More from Bardy Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233110 | Carnation Ambulatory MonitorDSH · Traditional | 11/22/2023SE |
| K210036 | Carnation Ambulatory Monitor (CAM)DSH · Special | 02/05/2021SE |
| K200870 | Carnation Ambulatory MonitorDSH · Special | 05/01/2020SE |
| K191471 | Carnation Ambulatory MonitorDSH · Special | 08/30/2019SE |
| K191000 | Carnation Ambulatory MonitorDSH · Special | 05/16/2019SE |
| K143067 | Carnation Ambulatory MonitorDSH · Traditional | 12/22/2014SE |
Questions and answers
When was Carnation Ambulatory Monitor cleared by the FDA?
Carnation Ambulatory Monitor (K192556) received a 510(k) decision of Substantially Equivalent on October 17, 2019, 30 days after the submission was received.
What is the product code of K192556?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.