Storz DX Center:Impedance Test W/Rhino & Audio Opt
FDA 510(k) K883293 · Storz Instrument Co.
510(k) numberK883293
Submission
- Device name
- Storz DX Center:Impedance Test W/Rhino & Audio Opt
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- August 4, 1988
- Decision date
- June 9, 1989
- 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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Questions and answers
When was Storz DX Center:Impedance Test W/Rhino & Audio Opt cleared by the FDA?
Storz DX Center:Impedance Test W/Rhino & Audio Opt (K883293) received a 510(k) decision of Substantially Equivalent on June 9, 1989, 309 days after the submission was received.
What is the product code of K883293?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.