Circa Med Two-Channel
FDA 510(k) K830830 · Circadian, Inc.
510(k) numberK830830
Submission
- Device name
- Circa Med Two-Channel
- Applicant
- Circadian, Inc.
Mchenry, IL, US - Received
- March 16, 1983
- Decision date
- June 18, 1983
- 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 |
|---|---|---|
| K921878 | Scanmate IIIIYP · Traditional | 09/11/1992SE |
| K894956 | Circamed Holter Version 4DPS · Traditional | 02/05/1990SE |
| K874641 | Circadian Stress Test IIDPS · Traditional | 04/01/1988SE |
| K874155 | Circamed Monitor Remote Start Conductance MeterKRC · Traditional | 11/23/1987SE |
| K871251 | Circamed Full Disclosure SystemDSI · Traditional | 05/22/1987SE |
| K860973 | Circadian Stress Test SystemDPS · Traditional | 08/25/1986SE |
| K851517 | Circa Med Single-Channel-Ambulatory Cardiac MonitoDSI · Traditional | 10/02/1985SE |
| K851643 | Remote Control ModuleDPS · Traditional | 09/09/1985SE |
| K840741 | Pulmonary Function Testing STSBZG · Traditional | 03/05/1984SE |
| K833619 | Conductance MeterKRC · Traditional | 01/27/1984SE |
Questions and answers
When was Circa Med Two-Channel cleared by the FDA?
Circa Med Two-Channel (K830830) received a 510(k) decision of Substantially Equivalent on June 18, 1983, 94 days after the submission was received.
What is the product code of K830830?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.