The following data is part of a premarket notification filed by Grass Instrument Co. with the FDA for Model S10ctcm Auditory Stimulator.
| Device ID | K810539 |
| 510k Number | K810539 |
| Device Name: | MODEL S10CTCM AUDITORY STIMULATOR |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | GRASS INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-27 |
| Decision Date | 1981-03-17 |