The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for The Screener Gsi 55 Abr Screener.
| Device ID | K870030 |
| 510k Number | K870030 |
| Device Name: | THE SCREENER GSI 55 ABR SCREENER |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | GRASON-STADLER, INC. 537 GREAT RD., P.O. BOX 1400 Littleton, MA 01460 |
| Contact | Janice E Painter |
| Correspondent | Janice E Painter GRASON-STADLER, INC. 537 GREAT RD., P.O. BOX 1400 Littleton, MA 01460 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-05 |
| Decision Date | 1987-03-13 |