Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite
FDA 510(k) K083861 · Interacoustics AS
510(k) numberK083861
Submission
- Device name
- Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite
- Applicant
- Interacoustics AS
Assens, DK - Received
- December 24, 2008
- Decision date
- April 9, 2009
- 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 |
| K121847 | TitanETY · Traditional | Interacoustics A/S | 11/29/2012SE |
| 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 |
|---|---|---|
| K090406 | EP15 Software Module, EP25 Software ModuleEWO · Traditional | 07/22/2009SE |
| K052562 | Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.EWO · Traditional | 12/23/2005SE |
| K043219 | Affinity (Cabinet Name), AC440, HIT440, or the Combination of SystemsEWO · Traditional | 02/04/2005SE |
Questions and answers
When was Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite cleared by the FDA?
Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite (K083861) received a 510(k) decision of Substantially Equivalent on April 9, 2009, 106 days after the submission was received.
What is the product code of K083861?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.