ABPMpro
FDA 510(k) K231104 · Somnomedics GmbH
510(k) numberK231104
Submission
- Device name
- ABPMpro
- Applicant
- Somnomedics GmbH
Randersacker, DE - Received
- April 19, 2023
- Decision date
- November 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code DSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K233110 | Carnation Ambulatory MonitorDSH · Traditional | Bardy Diagnostics, Inc. | 11/22/2023SE |
| K230184 | Holter ECG and ABP SystemDSH · Traditional | Edan Instruments, Inc. | 09/25/2023SE |
More from Edan Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240700 | HomeSleepTest (HST, HST REM+)OLV · Traditional | 12/08/2024SE |
| K212325 | EEG-acpGYB · Traditional | 06/15/2022SE |
| K201054 | SOMNOscreen plusOLV · Traditional | 08/12/2020SE |
| K140861 | Somnotouch RespMNR · Traditional | 01/30/2015SE |
| K081485 | SomnowatchMNR · Traditional | 09/18/2008SE |
| K071556 | Somnoscreen EEG10-20MNR · Special | 07/18/2007SE |
| K060708 | SomnoscreenMNR · Traditional | 01/24/2007SE |
Questions and answers
When was ABPMpro cleared by the FDA?
ABPMpro (K231104) received a 510(k) decision of Substantially Equivalent on November 27, 2023, 222 days after the submission was received.
What is the product code of K231104?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.