The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m Red Dot 2237 Sticky Gel Monitoring Ecg Electrode.
| Device ID | K934333 |
| 510k Number | K934333 |
| Device Name: | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | Linda Johnsen |
| Correspondent | Linda Johnsen 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-07-07 |