The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for Visualax.
Device ID | K781634 |
510k Number | K781634 |
Device Name: | VISUALAX |
Classification | Device, Biofeedback |
Applicant | FARRALL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-22 |
Decision Date | 1978-10-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISUALAX 97009666 not registered Live/Pending |
VISUALAX LTD 2021-09-02 |