Cleared Traditional

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

K071462 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat
Jun 2007
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K071462 is an FDA 510(k) clearance for the UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2), a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 5, 2007, 11 days after receiving the submission on May 25, 2007. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K071462 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2007
Decision Date June 05, 2007
Days to Decision 11 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3310