The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes.
Device ID | K971444 |
510k Number | K971444 |
Device Name: | 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES |
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 | 1997-04-21 |
Decision Date | 1997-06-11 |
Summary: | summary |