ICS IMPULSE

Nystagmograph

GN OTOMETRICS

The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Ics Impulse.

Pre-market Notification Details

Device IDK122550
510k NumberK122550
Device Name:ICS IMPULSE
ClassificationNystagmograph
Applicant GN OTOMETRICS 8870 RAVELLO CT Naples,  FL  34114
ContactDaniel Kamm
CorrespondentDaniel Kamm
GN OTOMETRICS 8870 RAVELLO CT Naples,  FL  34114
Product CodeGWN  
CFR Regulation Number882.1460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-21
Decision Date2013-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05713315005862 K122550 000
05713315008566 K122550 000
05713315008467 K122550 000
05713315003271 K122550 000
05713315008375 K122550 000
05713315008382 K122550 000
05713315008399 K122550 000
05713315008405 K122550 000
05713315008412 K122550 000
05713315008368 K122550 000
05713315003295 K122550 000
05713315005237 K122550 000
05713315004148 K122550 000
05713315004940 K122550 000
05713315005244 K122550 000
05713315005268 K122550 000
05713315005282 K122550 000
05713315008443 K122550 000

Trademark Results [ICS IMPULSE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ICS IMPULSE
ICS IMPULSE
79090517 3964680 Live/Registered
Natus Medical Incorporated
2010-10-16

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