The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Diagnostic Audiometer, Model Midimate 602.
| Device ID | K883478 |
| 510k Number | K883478 |
| Device Name: | DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 |
| Classification | Audiometer |
| Applicant | MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Contact | Zoila Flores |
| Correspondent | Zoila Flores MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-16 |
| Decision Date | 1988-11-17 |