HANDTYMP
FDA 510(k) clearance K923072 · decided 1993-03-18
Clearance details
- K-number
- K923072
- Device name
- HANDTYMP
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-25
- Decision date
- 1993-03-18
- Days to decision
- 266 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
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Hearing Healthcare Pro (K183201) | Db Diagnostic Systems, Inc. | 2019-03-06 |
| Hearing Healthcare Pro (K171038) | Db Diagnostic Systems, Inc. | 2017-08-02 |
| touchTymp (K162210) | Maico Diagnostics GmbH | 2016-11-16 |
| Madsen Zodiac (K161707) | Gn Otometrics | 2016-09-01 |
| AT235 (K151616) | Interacoustics A/S | 2015-07-15 |
| GSI TympStar Pro Middle Ear Analyzer (K151509) | Diagnostic Group, Dba Grason-Stadler | 2015-06-25 |
| 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.