The following data is part of a premarket notification filed by Minnesota Mining And Mfg. Co. with the FDA for 3m Red Dot Ecg Lead Wires A.
Device ID | K954900 |
510k Number | K954900 |
Device Name: | 3M RED DOT ECG LEAD WIRES A |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
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 | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-25 |
Decision Date | 1996-07-15 |
Summary: | summary |