Audx Otoacoustic Emissions Measurement System with Audx I/O Function
FDA 510(k) K111618 · Natus Medical Incorporated
510(k) numberK111618
Submission
- Device name
- Audx Otoacoustic Emissions Measurement System with Audx I/O Function
- Applicant
- Natus Medical Incorporated
San Francisco, CA, US - Received
- June 10, 2011
- Decision date
- December 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EWO – Audiometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1050
- Specialty
- Ear, Nose, Throat
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Questions and answers
When was Audx Otoacoustic Emissions Measurement System with Audx I/O Function cleared by the FDA?
Audx Otoacoustic Emissions Measurement System with Audx I/O Function (K111618) received a 510(k) decision of Substantially Equivalent on December 28, 2011, 201 days after the submission was received.
What is the product code of K111618?
The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.