The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Red Dot 2234 Radiolucent Monitoring Electrode.
| Device ID | K930312 |
| 510k Number | K930312 |
| Device Name: | 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Julia L Wannamaker |
| Correspondent | Julia L Wannamaker 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1993-09-01 |