Cambridge VS-550 Electrocardiograph
FDA 510(k) K800566 · Cambridge Instruments, Inc.
510(k) numberK800566
Submission
- Device name
- Cambridge VS-550 Electrocardiograph
- Applicant
- Cambridge Instruments, Inc.
Mchenry, IL, US - Received
- March 13, 1980
- Decision date
- April 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo Corporation
| 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 |
| 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 Cambridge VS-550 Electrocardiograph cleared by the FDA?
Cambridge VS-550 Electrocardiograph (K800566) received a 510(k) decision of Substantially Equivalent on April 8, 1980, 26 days after the submission was received.
What is the product code of K800566?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.