510(k) K885171 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
| Applicant | Andover Medical, Inc., Haverhill MA, US |
| Decision | Substantially Equivalent, Jan 12, 1989 |
| Received | Dec 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885171
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.