Algo 5 Newborn Hearing Screener
FDA 510(k) K073665 · Natus Medical, Inc.
510(k) numberK073665
Submission
- Device name
- Algo 5 Newborn Hearing Screener
- Applicant
- Natus Medical, Inc.
San Carlos, CA, US - Received
- December 26, 2007
- Decision date
- January 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Algo 5 Newborn Hearing Screener cleared by the FDA?
Algo 5 Newborn Hearing Screener (K073665) received a 510(k) decision of Substantially Equivalent on January 25, 2008, 30 days after the submission was received.
What is the product code of K073665?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.