Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System
FDA 510(k) K012206 · Cambridge Heart, Inc.
510(k) numberK012206
Submission
- Device name
- Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System
- Applicant
- Cambridge Heart, Inc.
South West Ranches, FL, US - Received
- July 13, 2001
- Decision date
- October 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
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| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 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 |
| K022149 | Cardiac Diagnostic System, Model CH2000DPS · 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 |
| 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 Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System cleared by the FDA?
Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System (K012206) received a 510(k) decision of Substantially Equivalent on October 12, 2001, 91 days after the submission was received.
What is the product code of K012206?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.