AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
FDA 510(k) clearance K854043 · decided 1985-12-31
Clearance details
- K-number
- K854043
- Device name
- AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
- Applicant
- Teledyne Avionics Div. of Teledyne
- Decision
- Substantially Equivalent
- Date received
- 1985-10-02
- Decision date
- 1985-12-31
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- ETY
- Device class
- 2
- Regulation number
- 874.1090
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
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| INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE (K133013) | Inventis S.R.L. | 2014-01-24 |
| TITAN (K121847) | Interacoustics A/S | 2012-11-29 |
| TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE (K083861) | Interacoustics AS | 2009-04-09 |
| AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (K081841) | Amplivox, Ltd. | 2008-07-16 |
| EARCHECK ACOUSTIC REFLECTOMETER (K070312) | Innovia Medical, LLC | 2007-03-02 |
| OTOFLEX 100 TYE 1012 (K033645) | Gn Otometrics A/S | 2004-03-31 |
Recalls involving this device
No recalls on record reference this clearance.