The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Insertion Gain Optimizer Igo-1000.
| Device ID | K854535 |
| 510k Number | K854535 |
| Device Name: | INSERTION GAIN OPTIMIZER IGO-1000 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Contact | Gleason |
| Correspondent | Gleason MADSEN ELECTRONICS (CANADA) LTD. 2370 SPEERS ROAD P.O. BOX 535 Oakville, Ontario, CA L6j5b4 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1986-02-20 |