The following data is part of a premarket notification filed by Grass Instrument Co. with the FDA for Model S10vs Visual Stimulator.
Device ID | K812061 |
510k Number | K812061 |
Device Name: | MODEL S10VS VISUAL STIMULATOR |
Classification | Stimulator, Photic, Evoked Response |
Applicant | GRASS INSTRUMENT CO. 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 | 1981-07-21 |
Decision Date | 1981-08-20 |