The following data is part of a premarket notification filed by Madsen Electronics (canada) Ltd. with the FDA for Hi-pro/noah Universal Hearing Instrument.
| Device ID | K942749 |
| 510k Number | K942749 |
| Device Name: | HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT |
| Classification | Hearing Aid, Air Conduction |
| 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 | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1994-07-18 |