The following data is part of a premarket notification filed by Minnesota Mining And Mfg. Co. with the FDA for 3m Red Dot Radiolucent Monitoring Electrode With Conductive Adhesive.
Device ID | K000690 |
510k Number | K000690 |
Device Name: | 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE |
Classification | Electrode, Electrocardiograph |
Applicant | MINNESOTA MINING AND MFG. CO. 3M CENTER St. Paul, MN 55144 -1000 |
Contact | Linda Johnson |
Correspondent | Linda Johnson MINNESOTA MINING AND MFG. CO. 3M CENTER 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 | 2000-02-29 |
Decision Date | 2000-05-17 |