The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Model 7320 Visual Stimulator.
Device ID | K781461 |
510k Number | K781461 |
Device Name: | MODEL 7320 VISUAL STIMULATOR |
Classification | Stimulator, Photic, Evoked Response |
Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GWE |
CFR Regulation Number | 882.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-18 |
Decision Date | 1978-11-08 |