The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Otoacoustic Emissions Unit Celesta 503.
| Device ID | K931325 |
| 510k Number | K931325 |
| Device Name: | OTOACOUSTIC EMISSIONS UNIT CELESTA 503 |
| Classification | Audiometer |
| Applicant | MADSEN ELECTRONICS (CANADA) LTD. 5600 ROWLAND RD. Minnetonka, MN 55343 |
| Contact | Marshall Rosner |
| Correspondent | Marshall Rosner MADSEN ELECTRONICS (CANADA) LTD. 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 | 1993-03-16 |
| Decision Date | 1994-02-18 |