Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute
FDA 510(k) K133013 · Inventis S.R.L.
510(k) numberK133013
Submission
- Device name
- Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute
- Applicant
- Inventis S.R.L.
Padova, IT - Received
- September 25, 2013
- Decision date
- January 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
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| K121847 | TitanETY · Traditional | Interacoustics A/S | 11/29/2012SE |
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…ETY · Traditional | Interacoustics AS | 04/09/2009SE |
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Questions and answers
When was Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute cleared by the FDA?
Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute (K133013) received a 510(k) decision of Substantially Equivalent on January 24, 2014, 121 days after the submission was received.
What is the product code of K133013?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.