Cleared Traditional

K102364 - NYDIAG 200 (FDA 510(k) Clearance)

K102364 · Interacoustics A/S · Ear, Nose, Throat device
Dec 2010
Decision
125d
Days
-
Risk

K102364 is an FDA 510(k) clearance for the NYDIAG 200. This device is classified as a Apparatus, Vestibular Analysis.

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on December 23, 2010, 125 days after receiving the submission on August 20, 2010.

This device falls under the Ear, Nose, Throat FDA review panel.

Submission Details

510(k) Number K102364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date December 23, 2010
Days to Decision 125 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXV - Apparatus, Vestibular Analysis
Device Class -