The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Phoenix System Seven..
| Device ID | K862592 |
| 510k Number | K862592 |
| Device Name: | PHOENIX SYSTEM SEVEN. |
| Classification | Audiometer |
| Applicant | NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Contact | Luich, P.e. |
| Correspondent | Luich, P.e. NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison, WI 53711 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-08 |
| Decision Date | 1986-09-16 |