510(k) K983196 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
| Applicant | Tz Medical, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Sep 15, 1999 |
| Received | Sep 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2013 | TZ Medical Inc. adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1.
Product Usage:
Used by trained professionals in hospitals, doctors offices, and Emergency M Terminated |
DRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.