The following data is part of a premarket notification filed by Madsen Electronics, Inc. with the FDA for Capella Cochlear Emissions Analyzer.
| Device ID | K983851 |
| 510k Number | K983851 |
| Device Name: | CAPELLA COCHLEAR EMISSIONS ANALYZER |
| Classification | Audiometer |
| Applicant | MADSEN ELECTRONICS, INC. 5600 ROWLAND RD. Minnetonka, MN 55343 |
| Contact | Tracy Millier |
| Correspondent | Tracy Millier MADSEN ELECTRONICS, INC. 5600 ROWLAND RD. Minnetonka, MN 55343 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-01-28 |