Cardiac Diagnostic System, Model CH2000
FDA 510(k) K022149 · Cambridge Heart, Inc.
510(k) numberK022149
Submission
- Device name
- Cardiac Diagnostic System, Model CH2000
- Applicant
- Cambridge Heart, Inc.
South West Ranches, FL, US - Received
- July 2, 2002
- Decision date
- July 16, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K100362 | Cambridge Heart OemDQK · Special | 04/14/2010SE |
| K050225 | Heartwave II Cardiac Diagnostic SystemDQK · Special | 04/07/2005SE |
| K022152 | Heartwave Alternans Processing System, Model ApsDPS · Special | 07/16/2002SE |
| K013565 | Cardiac Diagnostic System, Model CH2000DPS · Special | 11/21/2001SE |
| K013564 | Modification to Heartwave Alternans Processing System, Model ApsDPS · Special | 11/21/2001SE |
| K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…DQK · Traditional | 10/12/2001SE |
| K011324 | Cambridge Heart Model CH 2000 Cardiac Diagnostic SystemDQK · Special | 05/23/2001SE |
| K010758 | Heartwave Alternans Processing System, ApsDPS · Special | 04/12/2001SE |
| K010756 | CH 2000 Cardiac Diagnostic SystemDQK · Special | 04/12/2001SE |
| K003492 | Analytic Spectral Method of Alternans Processing; CH 2000 Cardiac Diagnostic System…DQK · Traditional | 01/18/2001SE |
Questions and answers
When was Cardiac Diagnostic System, Model CH2000 cleared by the FDA?
Cardiac Diagnostic System, Model CH2000 (K022149) received a 510(k) decision of Substantially Equivalent on July 16, 2002, 14 days after the submission was received.
What is the product code of K022149?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.