The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Dbte Hearing Aid: Digital & Programmable.
| Device ID | K897154 |
| 510k Number | K897154 |
| Device Name: | NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-04-30 |