Cardiobeeper II
FDA 510(k) K883843 · Survival Technology, Inc.
510(k) numberK883843
Submission
- Device name
- Cardiobeeper II
- Applicant
- Survival Technology, Inc.
Bethesda, MD, US - Received
- September 12, 1988
- Decision date
- November 9, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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|---|---|---|---|
| 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 |
|---|---|---|
| K925535 | Cardiobeeper(R) Cb-IiaDXH · Traditional | 01/28/1993SE |
| K894799 | Cardiobeeper Memory Monitor CB 600 SeriesDXH · Traditional | 10/03/1989SE |
| K890461 | Cardiobeeper IVDXH · Traditional | 02/23/1989SE |
| K883614 | Cytoguard(R)FMF · Traditional | 09/15/1988SE |
| K880300 | Cardiobeeper(R) IIIDXH · Traditional | 05/12/1988SE |
| K844966 | Cardiobeeper Profile MonitorDXH · Traditional | 02/08/1985SE |
| K822093 | Stat-ScanDXG · Traditional | 09/21/1982SE |
| K813101 | Cardiobeeper Memory MonitorDXY · Traditional | 11/27/1981SE |
| K772178 | Pacer Monitor, Pulse WidthDXH · Traditional | 12/08/1977SE |
Questions and answers
When was Cardiobeeper II cleared by the FDA?
Cardiobeeper II (K883843) received a 510(k) decision of Substantially Equivalent on November 9, 1988, 58 days after the submission was received.
What is the product code of K883843?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.