Titan
FDA 510(k) K121847 · Interacoustics A/S
510(k) numberK121847
Submission
- Device name
- Titan
- Applicant
- Interacoustics A/S
Assens, DK - Received
- June 25, 2012
- Decision date
- November 29, 2012
- 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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| K183201 | Hearing Healthcare ProETY · Traditional | Db Diagnostic Systems, Inc. | 03/06/2019SE |
| K171038 | Hearing Healthcare ProETY · Traditional | Db Diagnostic Systems, Inc. | 08/02/2017SE |
| K162210 | touchTympETY · Special | Maico Diagnostics GmbH | 11/16/2016SE |
| K161707 | Madsen ZodiacETY · Special | Gn Otometrics | 09/01/2016SE |
| K151616 | AT235ETY · Special | Interacoustics A/S | 07/15/2015SE |
| K151509 | GSI TympStar Pro Middle Ear AnalyzerETY · Traditional | Diagnostic Group, Dba Grason-Stadler | 06/25/2015SE |
| K133013 | Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus…ETY · Traditional | Inventis S.R.L. | 01/24/2014SE |
| K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…ETY · Traditional | Interacoustics AS | 04/09/2009SE |
| K081841 | Amplivox Otowave 102 Hand Held Portable TympanometerETY · Traditional | Amplivox, Ltd. | 07/16/2008SE |
| K070312 | Earcheck Acoustic ReflectometerETY · Special | Innovia Medical, LLC | 03/02/2007SE |
More from Innovia Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K200534 | VisualEyesGWN · Traditional | 08/12/2020SE |
| K200529 | OrionLXV · Traditional | 08/12/2020SE |
| K192652 | TRVLXV · Traditional | 05/27/2020SE |
| K191372 | LyraEWO · Traditional | 07/15/2019SE |
| K173567 | SeraEWO · Traditional | 02/14/2018SE |
| K163149 | VisualEyesGWN · Traditional | 04/26/2017SE |
| K162037 | Eclipse with VEMPGWJ · Traditional | 03/23/2017SE |
| K152112 | VisualEyesGWN · Traditional | 12/29/2015SE |
| K151616 | AT235ETY · Special | 07/15/2015SE |
| K131681 | Eyeseecam VhitGWN · Traditional | 09/06/2013SE |
Questions and answers
When was Titan cleared by the FDA?
Titan (K121847) received a 510(k) decision of Substantially Equivalent on November 29, 2012, 157 days after the submission was received.
What is the product code of K121847?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.