OTOFLEX 100 TYE 1012

Tester, Auditory Impedance

GN OTOMETRICS A/S

The following data is part of a premarket notification filed by Gn Otometrics A/s with the FDA for Otoflex 100 Tye 1012.

Pre-market Notification Details

• Device ID: K033645
• 510k Number: K033645
• Device Name: OTOFLEX 100 TYE 1012
• Classification: Tester, Auditory Impedance
• Applicant: GN OTOMETRICS A/S DYBENDALSVAENGET 2 P.O. BOX 119 Taastrup, DK Dk-2630
• Contact: Per Pape Thomsen
• Correspondent: Per Pape Thomsen; GN OTOMETRICS A/S DYBENDALSVAENGET 2 P.O. BOX 119 Taastrup, DK Dk-2630
• Product Code: ETY
• CFR Regulation Number: 874.1090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-20
• Decision Date: 2004-03-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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