K870030 is an FDA 510(k) clearance for the THE SCREENER GSI 55 ABR SCREENER. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Grason-Stadler, Inc. (Littleton, US). The FDA issued a Cleared decision on March 13, 1987, 67 days after receiving the submission on January 5, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K870030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1987 |
| Decision Date | March 13, 1987 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWJ — Stimulator, Auditory, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1900 |