3038 Option B-Comput. Trans. Terminal
FDA 510(k) K761318 · Cambridge Instruments, Inc.
510(k) numberK761318
Submission
- Device name
- 3038 Option B-Comput. Trans. Terminal
- Applicant
- Cambridge Instruments, Inc.
Mchenry, IL, US - Received
- December 27, 1976
- Decision date
- January 6, 1977
- 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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More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K790509 | Cardiocassette II, Ambulatory ECG SystemDSH · Traditional | 03/23/1979SE |
| 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 3038 Option B-Comput. Trans. Terminal cleared by the FDA?
3038 Option B-Comput. Trans. Terminal (K761318) received a 510(k) decision of Substantially Equivalent on January 6, 1977, 10 days after the submission was received.
What is the product code of K761318?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.