The Beta
FDA 510(k) K810940 · Burdick Corp.
510(k) numberK810940
Submission
- Device name
- The Beta
- Applicant
- Burdick Corp.
Mchenry, IL, US - Received
- April 7, 1981
- Decision date
- July 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
More from Memtec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K952417 | Quest Exercise Stress SystemDSI · Traditional | 05/22/1996SE |
| K954267 | Burdick 200 Pulse OximeterDQA · Traditional | 05/03/1996SE |
| K946281 | Eclipse 4 ElectrocardiographLOS · Traditional | 04/23/1996SE |
| K945985 | PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400DQK · Traditional | 07/03/1995SE |
| K943959 | Eclipse 4 ElectrocardiographLOS · Traditional | 05/17/1995SE |
| K942565 | Altair-Disc RecorderDQK · Traditional | 12/05/1994SE |
| K941351 | Burdick PRO2 OximeterDQA · Traditional | 10/13/1994SE |
| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
| K904032 | Elite II ElectrocardiographLOS · Traditional | 07/24/1991SE |
| K903565 | E560 ElectrocardiographLOS · Traditional | 07/24/1991SE |
Questions and answers
When was The Beta cleared by the FDA?
The Beta (K810940) received a 510(k) decision of Substantially Equivalent on July 16, 1981, 100 days after the submission was received.
What is the product code of K810940?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.