Automatic Impedance Audiometer, TA-7B
FDA 510(k) K854043 · Teledyne Avionics Div. of Teledyne
510(k) numberK854043
Submission
- Device name
- Automatic Impedance Audiometer, TA-7B
- Applicant
- Teledyne Avionics Div. of Teledyne
Charlottesville, VA, US - Received
- October 2, 1985
- Decision date
- December 31, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETY – Tester, Auditory Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Specialty
- Ear, Nose, Throat
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More from Amplivox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K860262 | TA-6C - Part Number SLZ 7520ETY · Traditional | 04/23/1986SE |
| K860522 | Spirometer, Model TS-1000, Part No. SLZ7504BZG · Traditional | 03/03/1986SE |
| K855068 | Spirometer, Model TS-500 Part #SLZ7534BTY · Traditional | 02/05/1986SE |
| K855070 | Spirometer Model TS-200 SLZ 7541BZC · Traditional | 01/30/1986SE |
| K855069 | Spirometer TS-400 SLZ 7547BTY · Traditional | 01/30/1986SE |
| K851015 | TA-20 Automatic Industiral AudiometerEWO · Traditional | 06/04/1985SE |
| K850461 | Automatic Impedance Meter TA-7AETY · Traditional | 03/25/1985SE |
| K844069 | TA-201 Clinical AudiometerEWO · Traditional | 12/03/1984SE |
| K811509 | Auto-Tympanigraph (TA-5A)ETY · Traditional | 06/16/1981SE |
| K801325 | Clinical Audiometer Model TA-200EWO · Traditional | 06/30/1980SE |
Questions and answers
When was Automatic Impedance Audiometer, TA-7B cleared by the FDA?
Automatic Impedance Audiometer, TA-7B (K854043) received a 510(k) decision of Substantially Equivalent on December 31, 1985, 90 days after the submission was received.
What is the product code of K854043?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.