ICS CHARTR EP 200

Stimulator, Auditory, Evoked Response

GN OTOMETRICS A/S

The following data is part of a premarket notification filed by Gn Otometrics A/s with the FDA for Ics Chartr Ep 200.

Pre-market Notification Details

• Device ID: K083399
• 510k Number: K083399
• Device Name: ICS CHARTR EP 200
• Classification: Stimulator, Auditory, Evoked Response
• Applicant: GN OTOMETRICS A/S 125 COMMERCE DRIVE Schaumburg, IL 60173 -5329
• Contact: Dan Sansonetti
• Correspondent: Dan Sansonetti; GN OTOMETRICS A/S 125 COMMERCE DRIVE Schaumburg, IL 60173 -5329
• Product Code: GWJ
• CFR Regulation Number: 882.1900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-17
• Decision Date: 2009-02-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713315008740	K083399	000
05713315002731	K083399	000
05713315002748	K083399	000
05713315002755	K083399	000
05713315002762	K083399	000
05713315002779	K083399	000
05713315002786	K083399	000
05713315002793	K083399	000
05713315002809	K083399	000
05713315002816	K083399	000
05713315002823	K083399	000
05713315002830	K083399	000
05713315002724	K083399	000
05713315002717	K083399	000
05713315002700	K083399	000
05713315008757	K083399	000
05713315008764	K083399	000
05713315008771	K083399	000
05713315008788	K083399	000
05713315008795	K083399	000
05713315008801	K083399	000
05713315002915	K083399	000
05713315002601	K083399	000
05713315002618	K083399	000
05713315002625	K083399	000
05713315002632	K083399	000
05713315002847	K083399	000
05713315002854	K083399	000
05713315002861	K083399	000
05713315003066	K083399	000
05713315003073	K083399	000
05713315003080	K083399	000
05713315003097	K083399	000
05713315003103	K083399	000
05713315003134	K083399	000
05713315003141	K083399	000
05713315003158	K083399	000
05713315003172	K083399	000
05713315003189	K083399	000
05713315005077	K083399	000
05713315003059	K083399	000
05713315003042	K083399	000
05713315003035	K083399	000
05713315002878	K083399	000
05713315002885	K083399	000
05713315002892	K083399	000
05713315002908	K083399	000
05713315002946	K083399	000
05713315002960	K083399	000
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05713315002984	K083399	000
05713315003004	K083399	000
05713315003011	K083399	000
05713315003028	K083399	000
05713315005084	K083399	000