Auto-Tympanigraph (TA-5A)
FDA 510(k) K811509 · Teledyne Avionics Div. of Teledyne
510(k) numberK811509
Submission
- Device name
- Auto-Tympanigraph (TA-5A)
- Applicant
- Teledyne Avionics Div. of Teledyne
Mchenry, IL, US - Received
- May 27, 1981
- Decision date
- June 16, 1981
- 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 |
| K854043 | Automatic Impedance Audiometer, TA-7BETY · Traditional | 12/31/1985SE |
| 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 |
| K801325 | Clinical Audiometer Model TA-200EWO · Traditional | 06/30/1980SE |
Questions and answers
When was Auto-Tympanigraph (TA-5A) cleared by the FDA?
Auto-Tympanigraph (TA-5A) (K811509) received a 510(k) decision of Substantially Equivalent on June 16, 1981, 20 days after the submission was received.
What is the product code of K811509?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.