Cardiocassette II, Ambulatory ECG System
FDA 510(k) K790509 · Cambridge Instruments, Inc.
510(k) numberK790509
Submission
- Device name
- Cardiocassette II, Ambulatory ECG System
- Applicant
- Cambridge Instruments, Inc.
Mchenry, IL, US - Received
- March 15, 1979
- Decision date
- March 23, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | Vitalograph , Ltd. | 12/03/2025SE |
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| K232670 | HiCardi+ H100DSH · Traditional | MEZOO Co., Ltd. | 09/20/2024SE |
| K233906 | S-Patch (S-Patch ExL)DSH · Special | Wellysis Corp. | 02/16/2024SE |
| K231104 | ABPMproDSH · Traditional | Somnomedics GmbH | 11/27/2023SE |
| K233110 | Carnation Ambulatory MonitorDSH · Traditional | Bardy Diagnostics, Inc. | 11/22/2023SE |
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|---|---|---|
| K811121 | Central Station Monitoring SystemsDPS · Traditional | 06/30/1981SE |
| K811062 | Campbridge ComputraceDXG · Traditional | 05/29/1981SE |
| K803229 | 4-CHANNEL ECG Telemetry Mon. Syst. #3045DRG · Traditional | 01/13/1981SE |
| K801224 | Cambridge Cardiac Diagnostic SystemDXK · Traditional | 06/26/1980SE |
| K800566 | Cambridge VS-550 ElectrocardiographDPS · Traditional | 04/08/1980SE |
| K792661 | Treadmill Model 3060IOL · Traditional | 02/19/1980SE |
| K791201 | Scintistress SystemDPS · Traditional | 09/17/1979SE |
| K761318 | 3038 Option B-Comput. Trans. TerminalDXH · Traditional | 01/06/1977SE |
| K761198 | Model 3044 3-CHANNEL Stress Test SystemDPS · Traditional | 12/09/1976SE |
| K760926 | Electrocardiograph (Model VS-4B)DPS · Traditional | 11/09/1976SE |
Questions and answers
When was Cardiocassette II, Ambulatory ECG System cleared by the FDA?
Cardiocassette II, Ambulatory ECG System (K790509) received a 510(k) decision of Substantially Equivalent on March 23, 1979, 8 days after the submission was received.
What is the product code of K790509?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.