The following data is part of a premarket notification filed by Idem (int'l Dist. Of Electronics For Medicine) with the FDA for Interacoustics Ep 15 Abr Stand Alone Unit.
| Device ID | K991853 |
| 510k Number | K991853 |
| Device Name: | INTERACOUSTICS EP 15 ABR STAND ALONE UNIT |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 4814 EAST SECOND ST. Benicia, CA 94510 |
| Contact | Donna Ward |
| Correspondent | Donna Ward IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 4814 EAST SECOND ST. Benicia, CA 94510 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-10-25 |
| Summary: | summary |