4-CHANNEL ECG Telemetry Mon. Syst. #3045
FDA 510(k) K803229 · Cambridge Instruments, Inc.
510(k) numberK803229
Submission
- Device name
- 4-CHANNEL ECG Telemetry Mon. Syst. #3045
- Applicant
- Cambridge Instruments, Inc.
Walker, MI, US - Received
- December 19, 1980
- Decision date
- January 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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More from Cardioline S.P.A
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| K811121 | Central Station Monitoring SystemsDPS · Traditional | 06/30/1981SE |
| K811062 | Campbridge ComputraceDXG · Traditional | 05/29/1981SE |
| 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 |
| K790509 | Cardiocassette II, Ambulatory ECG SystemDSH · Traditional | 03/23/1979SE |
| 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 4-CHANNEL ECG Telemetry Mon. Syst. #3045 cleared by the FDA?
4-CHANNEL ECG Telemetry Mon. Syst. #3045 (K803229) received a 510(k) decision of Substantially Equivalent on January 13, 1981, 25 days after the submission was received.
What is the product code of K803229?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.