The following data is part of a premarket notification filed by Auditdata A/s with the FDA for Primus Hearing Instrument Test Unit.
| Device ID | K113831 |
| 510k Number | K113831 |
| Device Name: | PRIMUS HEARING INSTRUMENT TEST UNIT |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | AUDITDATA A/S BANESTROEGER 13 Taastrup, DK Dk-2630 |
| Contact | Dan Haugbol |
| Correspondent | Dan Haugbol AUDITDATA A/S BANESTROEGER 13 Taastrup, DK Dk-2630 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-04-19 |
| Summary: | summary |