510(k) K002230 ยท DRX Electrode, Electrocardiograph
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
| Applicant | Cambridge Heart, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Aug 18, 2000 |
| Received | Jul 24, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2010 | Cambridge Heart, Inc. The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test. Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.