Automatic Tympanometer
FDA 510(k) K923073 · Life-Tech Intl., Inc.
510(k) numberK923073
Submission
- Device name
- Automatic Tympanometer
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- June 25, 1992
- Decision date
- February 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was Automatic Tympanometer cleared by the FDA?
Automatic Tympanometer (K923073) received a 510(k) decision of Substantially Equivalent on February 19, 1993, 239 days after the submission was received.
What is the product code of K923073?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.