K133013 is an FDA 510(k) clearance for the INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE. This device is classified as a Tester, Auditory Impedance (Class II - Special Controls, product code ETY).
Submitted by Inventis S.R.L. (Padova, IT). The FDA issued a Cleared decision on January 24, 2014, 121 days after receiving the submission on September 25, 2013.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1090.
| 510(k) Number | K133013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2013 |
| Decision Date | January 24, 2014 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETY - Tester, Auditory Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1090 |