The following data is part of a premarket notification filed by Lectec Corp. with the FDA for Synkara.
Device ID | K840445 |
510k Number | K840445 |
Device Name: | SYNKARA |
Classification | Electrode, Electrocardiograph |
Applicant | LECTEC CORP. 10205 CROSSTOWN CIRCLE Eden Prairie , MN 55344 - |
Contact | Daniel R Vieths |
Correspondent | Daniel R Vieths LECTEC CORP. 10205 CROSSTOWN CIRCLE Eden Prairie , MN 55344 - |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-30 |
Decision Date | 1985-05-16 |