Ics Impulse
FDA 510(k) K122550 · Gn Otometrics
510(k) numberK122550
Submission
- Device name
- Ics Impulse
- Applicant
- Gn Otometrics
Naples, FL, US - Received
- August 21, 2012
- Decision date
- February 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K161707 | Madsen ZodiacETY · Special | 09/01/2016SE |
| K151504 | ICS ImpulseGWN · Traditional | 11/16/2015SE |
| K132957 | Madsen Accuscreen Type 1077GWJ · Traditional | 02/27/2014SE |
| 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 Ics Impulse cleared by the FDA?
Ics Impulse (K122550) received a 510(k) decision of Substantially Equivalent on February 1, 2013, 164 days after the submission was received.
What is the product code of K122550?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.