Madsen Zodiac
K-Number: K161707 · 2016-09-01
ApplicantGn Otometrics
Decision Date2016-09-01
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Madsen Zodiac is a medical device manufactured by Gn Otometrics. It received FDA 510(k) clearance on 2016-09-01 under approval number K161707. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Madsen Zodiac?
Madsen Zodiac is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Gn Otometrics. The 510(k) number is K161707.
When was Madsen Zodiac approved by the FDA?
Madsen Zodiac received FDA 510(k) clearance on 2016-09-01, under approval number K161707.
What company makes Madsen Zodiac?
Madsen Zodiac is manufactured by Gn Otometrics.
What is the FDA product code for Madsen Zodiac?
The FDA product code for Madsen Zodiac is ETY.
Related Devices (Code: ETY)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.