Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710,ER720
FDA 510(k) K981394 · Braemar Corp.
510(k) numberK981394
Submission
- Device name
- Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710,ER720
- Applicant
- Braemar Corp.
Burnsville, MN, US - Received
- April 17, 1998
- Decision date
- September 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
Other 510(k)s with product code DXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDKDXH · Traditional | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 02/13/2026SE |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional | Heartbeam, Inc. | 12/08/2025SE |
| K243438 | MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional | Huinno Co., Ltd. | 12/05/2025SE |
| K243981 | Hexoskin Medical System (7100-00016)DXH · Traditional | Carre Technologies, Inc. | 11/18/2025SE |
| K243003 | VitalSigns 1-Lead Holter (VSH101)DXH · Traditional | VitalSigns Technology Co., Ltd. | 06/17/2025SE |
| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional | Verily Life Sciences, LLC | 07/19/2022SE |
| K220350 | KardiaMobile 6LDXH · Traditional | AliveCor, Inc. | 05/25/2022SE |
More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081444 | Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring SystemDSI · Traditional | 07/31/2008SE |
| K072008 | Braemar ER900 Wireless Series Arrhythmia Event RecorderDRG · Traditional | 10/03/2007SE |
| K071733 | DL900 Series Holter RecorderMWJ · Special | 07/24/2007SE |
| K071011 | Modification to: Braemar ER900 Series Enhanced Algorithm ECG Event RecorderMWJ · Special | 04/27/2007SE |
| K042469 | Braemar ER800 Series Enhanced Algorithm Event RecorderMWJ · Traditional | 10/06/2004SE |
| K030856 | ER800 Series ECG Event RecorderMWJ · Special | 03/28/2003SE |
| K993618 | DXP1000 Holter RecorderMWJ · Special | 11/24/1999SE |
| K993617 | Digitrakplus Holter RecorderMWJ · Special | 11/24/1999SE |
| K945130 | Braemar Model DL700 Ambulatory Electrocardiographic RecorderDSH · Traditional | 04/12/1995SE |
Questions and answers
When was Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710,ER720 cleared by the FDA?
Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710,ER720 (K981394) received a 510(k) decision of Substantially Equivalent on September 28, 1998, 164 days after the submission was received.
What is the product code of K981394?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.