CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
FDA 510(k) clearance K002230 · decided 2000-08-18
Clearance details
- K-number
- K002230
- Device name
- CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
- Applicant
- Cambridge Heart, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-24
- Decision date
- 2000-08-18
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- DRX
- Device class
- 2
- Regulation number
- 870.2360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- South West Ranches, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary f recall (Z-1776-2010) | Cambridge Heart, Inc. | 2010-06-07 |