510(k) K133013
- Device
- INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
- Applicant
- INVENTIS SRL
- 510(k) number
- K133013
- Product code
- ETY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-24
- Date received
- 2013-09-25
- Regulation
- 874.1090
- Classification name
- Tester, Auditory Impedance
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MASSIMO MARTINELLI
- Address
- Corso Stati Uniti 1/3 Padova IT 35127 35127
FDA Registration Numbers#
- 3005581270
- 3008111228
- 3003138182
- 3011310592
- 9710051
- 3010608097
- 3034880867
- 2113281
- 3002504821
- 1316463
- 3013298431
- 3006285900
- 9612197
Source Documents#
Other 510(k) Records For Product Code ETY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2019-03-06 |
| K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017-08-02 |
| K162210 | touchTymp | Maico Diagnostics GmbH | 2016-11-16 |
| K161707 | Madsen Zodiac | Gn Otometrics | 2016-09-01 |
| K151616 | AT235 | Interacoustics A/S | 2015-07-15 |
| K151509 | GSI TympStar Pro Middle Ear Analyzer | Diagnostic Group, Dba Grason-Stadler | 2015-06-25 |
| K121847 | TITAN | Interacoustics A/S | 2012-11-29 |
| K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | Interacoustics AS | 2009-04-09 |
| K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | Amplivox, Ltd. | 2008-07-16 |
| K070312 | EARCHECK ACOUSTIC REFLECTOMETER | Innovia Medical, LLC | 2007-03-02 |
| K033645 | OTOFLEX 100 TYE 1012 | Gn Otometrics A/S | 2004-03-31 |
| K031978 | AMPLAID A756 SCREENING ADMITTANCE METER | Amplaid | 2003-07-21 |
| K022728 | AUDIOTRAVELLER, MODEL AA222 | Interacoustics A/S, Assens | 2002-10-11 |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | Grason-Stadler, Inc. | 2000-04-12 |
| K994254 | INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER | International Distributors of Electronics For Medi | 2000-03-14 |
Legacy Summary#
summary
FDA Review#
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