Cambridge Heart Oem
FDA 510(k) K100362 · Cambridge Heart, Inc.
510(k) numberK100362
Submission
- Device name
- Cambridge Heart Oem
- Applicant
- Cambridge Heart, Inc.
South West Ranches, FL, US - Received
- February 12, 2010
- Decision date
- April 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 Cambridge Heart Oem cleared by the FDA?
Cambridge Heart Oem (K100362) received a 510(k) decision of Substantially Equivalent on April 14, 2010, 61 days after the submission was received.
What is the product code of K100362?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.