The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Vitatrace.
Device ID | K893425 |
510k Number | K893425 |
Device Name: | VITATRACE |
Classification | Electrode, Electrocardiograph |
Applicant | LECTEC CORP. 10701 RED CIRCLE DR. Minnetonka, MN 55343 |
Contact | David Montecalvo |
Correspondent | David 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 | 1989-05-02 |
Decision Date | 1989-07-14 |