The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Tracets Sme 5000.
Device ID | K912450 |
510k Number | K912450 |
Device Name: | TRACETS SME 5000 |
Classification | Electrode, Electrocardiograph |
Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Contact | David A Montecalvo |
Correspondent | David A Montecalvo LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-03 |
Decision Date | 1991-08-28 |