510(k) K962128 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
| Applicant | Hemo Sapiens, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 21, 1996 |
| Received | Jun 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962128
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.