Cleared Traditional

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE

K952098 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat
May 1995
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K952098 is an FDA 510(k) clearance for the SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE, 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 May 25, 1995, 21 days after receiving the submission on May 4, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K952098 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1995
Decision Date May 25, 1995
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

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