510(k) K921216 ยท DQK Computer, Diagnostic, Programmable
OFF-LINE ANALYSIS SYSTEM
| Applicant | Softheart, Inc., Charlotte VT, US |
| Decision | Substantially Equivalent, Nov 20, 1992 |
| Received | Mar 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921216
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.