Submission Details
| 510(k) Number | K113831 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 2011 |
| Decision Date | April 19, 2012 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
PRIMUS HEARING INSTRUMENT TEST UNIT
Apr 2012
Decision
114d
Days
Class 2
Risk
About This 510(k) Submission
K113831 is an FDA 510(k) clearance for the PRIMUS HEARING INSTRUMENT TEST UNIT, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Auditdata A/S (Taastrup, DK). The FDA issued a Cleared decision on April 19, 2012, 114 days after receiving the submission on December 27, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.
Device Classification
| Product Code | ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3310 |
Manufacturer
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