The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Gn Otometrics Insert Earphones.
| Device ID | K081234 |
| 510k Number | K081234 |
| Device Name: | GN OTOMETRICS INSERT EARPHONES |
| Classification | Audiometer |
| Applicant | GN OTOMETRICS 125 E. COMMERCE DRIVE Schaumburg, IL 60173 |
| Contact | Daniel Sansonetti |
| Correspondent | Daniel Sansonetti GN OTOMETRICS 125 E. COMMERCE DRIVE Schaumburg, IL 60173 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-01 |
| Decision Date | 2008-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315005091 | K081234 | 000 |
| 05713315008252 | K081234 | 000 |