The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Real Ear Analyzer.
| Device ID | K896477 |
| 510k Number | K896477 |
| Device Name: | NICOLET REAL EAR ANALYZER |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| 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 | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-13 |
| Decision Date | 1990-02-08 |