ETY — Tester, Auditory Impedance Class II
FDA product code ETY covers "Tester, Auditory Impedance", a Class II medical device regulated under 21 CFR 874.1090. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ETY
- Device Class
- Class II
- Regulation Number
- 874.1090
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183201 | db diagnostic systems | Hearing Healthcare Pro | March 6, 2019 |
| K171038 | db diagnostic systems | Hearing Healthcare Pro | August 2, 2017 |
| K162210 | maico diagnostics | touchTymp | November 16, 2016 |
| K161707 | gn otometrics | Madsen Zodiac | September 1, 2016 |
| K151616 | interacoustics | AT235 | July 15, 2015 |
| K151509 | diagnostic group, dba grason-stadler | GSI TympStar Pro Middle Ear Analyzer | June 25, 2015 |
| K133013 | inventis | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE P | January 24, 2014 |
| K121847 | interacoustics | TITAN | November 29, 2012 |
| K083861 | interacoustics | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MOD | April 9, 2009 |
| K081841 | amplivox | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | July 16, 2008 |
| K070312 | innovia medical | EARCHECK ACOUSTIC REFLECTOMETER | March 2, 2007 |
| K033645 | gn otometrics | OTOFLEX 100 TYE 1012 | March 31, 2004 |
| K031978 | amplaid | AMPLAID A756 SCREENING ADMITTANCE METER | July 21, 2003 |
| K022728 | interacoustics a/s, assens | AUDIOTRAVELLER, MODEL AA222 | October 11, 2002 |
| K000097 | grason-stadler | GSI 2000 MIDDLE EAR ANALYZER | April 12, 2000 |
| K994254 | international distributors of electronics for medi | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER | March 14, 2000 |
| K991562 | pascal medical | PASCAL MEDICAL AB MENIETT 20 | December 28, 1999 |
| K992370 | amplifon | AMPLAID A724 AND A728 | September 20, 1999 |
| K990585 | idem (int'l dist. of electronics for medicine) | INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER | May 17, 1999 |
| K990652 | idem (int'l dist. of electronics for medicine) | INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER | May 17, 1999 |