TYPE 1077 ACCUSCREEN

Stimulator, Auditory, Evoked Response

GN OTOMETRICS

The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Type 1077 Accuscreen.

Pre-market Notification Details

• Device ID: K122067
• 510k Number: K122067
• Device Name: TYPE 1077 ACCUSCREEN
• Classification: Stimulator, Auditory, Evoked Response
• Applicant: GN OTOMETRICS HOERSKAETTEN 9 Taatrup, DK Dk-2630
• Contact: Tom Riniker
• Correspondent: Paula Wilkerson; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: GWJ
• CFR Regulation Number: 882.1900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-07-16
• Decision Date: 2012-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713315003363	K122067	000
05713315000287	K122067	000
05713315000294	K122067	000
05713315000300	K122067	000
05713315000317	K122067	000
05713315000324	K122067	000
05713315003219	K122067	000
05713315003356	K122067	000
05713315003455	K122067	000
05713315003486	K122067	000
05713315003806	K122067	000
05713315003943	K122067	000
05713315005497	K122067	000
05713315003431	K122067	000
05713315003448	K122067	000
05713315003370	K122067	000
05713315003950	K122067	000
05713315003967	K122067	000
05713315003974	K122067	000
05713315003981	K122067	000
05713315003998	K122067	000
05713315005473	K122067	000
05713315005480	K122067	000
05713315003813	K122067	000
05713315003820	K122067	000
05713315003837	K122067	000
05713315004544	K122067	000
05713315004643	K122067	000
05713315004650	K122067	000
05713315004667	K122067	000
05713315004698	K122067	000
05713315004711	K122067	000
05713315004728	K122067	000
05713315004926	K122067	000
05713315005336	K122067	000
05713315005343	K122067	000
05713315004209	K122067	000
05713315004193	K122067	000
05713315003844	K122067	000
05713315003851	K122067	000
05713315003868	K122067	000
05713315003875	K122067	000
05713315003882	K122067	000
05713315003899	K122067	000
05713315003905	K122067	000
05713315004162	K122067	000
05713315004179	K122067	000
05713315004186	K122067	000
05713315005442	K122067	000