510(k) K905446 ยท DRX Electrode, Electrocardiograph
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
| Applicant | Medtronic Andover Medical, Inc., Haverhill MA, US |
| Decision | Substantially Equivalent, Feb 5, 1991 |
| Received | Dec 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2003 | Conmed Corporation 1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1690-001 (1 unit per pouch/30 per b Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.