510(k) K970796 ยท DRX Electrode, Electrocardiograph
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
| Applicant | 3M Healthcare, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 9, 1997 |
| Received | Mar 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2020 | 3M Company - Health Care Business Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel
- Product Usage: intended to be used by healthcare professionals for ECG monitoring.
5 electrodes per card; 1 card per
pouch; 200 pouches p Terminated |
DRX | None listed |
| Sep 15, 2020 | 3M Company - Health Care Business Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel
- Product Usage: intended to be used by healthcare professionals for ECG monitoring.
3 electrodes per card; 1 card per pouch; 200 pouches p Terminated |
DRX | None listed |
| Sep 15, 2020 | 3M Company - Health Care Business 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring.
10 electrodes per card; 4 cards per pouch; 20 pouches per shipper Terminated |
DRX | None listed |
| Sep 15, 2020 | 3M Company - Health Care Business 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring.
50 electrodes per pouch; 20 pouches per shipper box (1000 electrode Terminated |
DRX | None listed |
| Sep 15, 2020 | 3M Company - Health Care Business 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring.
50 electrodes per pouch; 20 pouches per shipper box (1000 electrode Terminated |
DRX | None listed |
| Sep 7, 2010 | 3M Company / Medical Division 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring. Terminated |
DRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.