Madsen Zodiac
FDA 510(k) K161707 · Gn Otometrics
510(k) numberK161707
Submission
- Device name
- Madsen Zodiac
- Applicant
- Gn Otometrics
Taastrup, DK - Received
- June 21, 2016
- Decision date
- September 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Innovia Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K151504 | ICS ImpulseGWN · Traditional | 11/16/2015SE |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | 02/27/2014SE |
| K122550 | Ics ImpulseGWN · Traditional | 02/01/2013SE |
| K122028 | Aurical HitETW · Traditional | 10/23/2012SE |
| K122067 | Type 1077 AccuscreenGWJ · Traditional | 09/27/2012SE |
| K092373 | Ics Chartr Ep 200GWJ · Special | 09/03/2009SE |
| K081234 | GN Otometrics Insert EarphonesEWO · Traditional | 07/14/2008SE |
Questions and answers
When was Madsen Zodiac cleared by the FDA?
Madsen Zodiac (K161707) received a 510(k) decision of Substantially Equivalent on September 1, 2016, 72 days after the submission was received.
What is the product code of K161707?
The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.