GSI TympStar Pro Middle Ear Analyzer
FDA 510(k) K151509 · Diagnostic Group, Dba Grason-Stadler
510(k) numberK151509
Submission
- Device name
- GSI TympStar Pro Middle Ear Analyzer
- Applicant
- Diagnostic Group, Dba Grason-Stadler
Eden Prairie, MN, US - Received
- June 4, 2015
- Decision date
- June 25, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
Questions and answers
When was GSI TympStar Pro Middle Ear Analyzer cleared by the FDA?
GSI TympStar Pro Middle Ear Analyzer (K151509) received a 510(k) decision of Substantially Equivalent on June 25, 2015, 21 days after the submission was received.
What is the product code of K151509?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.