The following data is part of a premarket notification filed by Miracle-ear/dahlberg, Inc. with the FDA for Dahlberg Model Gf Microprocessor Audiometer.
| Device ID | K854835 |
| 510k Number | K854835 |
| Device Name: | DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER |
| Classification | Audiometer |
| Applicant | MIRACLE-EAR/DAHLBERG, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
| Contact | Jane E Hixson |
| Correspondent | Jane E Hixson MIRACLE-EAR/DAHLBERG, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-03 |
| Decision Date | 1986-03-04 |