Otoflex 100 Tye 1012
FDA 510(k) K033645 · Gn Otometrics A/S
510(k) numberK033645
Submission
- Device name
- Otoflex 100 Tye 1012
- Applicant
- Gn Otometrics A/S
Taastrup, DK - Received
- November 20, 2003
- Decision date
- March 31, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Otoflex 100 Tye 1012 cleared by the FDA?
Otoflex 100 Tye 1012 (K033645) received a 510(k) decision of Substantially Equivalent on March 31, 2004, 132 days after the submission was received.
What is the product code of K033645?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.