Cleared Traditional

K070696 - INTERACOUSTICS ASSR

K070696 is the FDA 510(k) clearance for INTERACOUSTICS ASSR by Interacoustics A/S. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K070696 · Interacoustics A/S · Neurology device
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Jun 2007
Decision
108d
Days
Class 2
Risk

K070696 is an FDA 510(k) clearance for the INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME). Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Interacoustics A/S (Minnesota, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Interacoustics A/S devices

Submission Details

510(k) Number K070696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date June 29, 2007
Days to Decision 108 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 148d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 8
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