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Siemens Pc Auidiometer Model Sd 100 & Pc Probe Mic System Model Sd 110/Sd with Unity Sopftware Suite

by Siemens Hearing Instruments, Inc.

510(k) K952098

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952098 Date25 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETW
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 874.3310
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a calibrator, hearing aid / earphone and analysis system. It is a PC-based audiometer system comprising the Siemens PC Audiometer Model SD 100 and the PC Probe Mic System Model SD 110/SD, used with the Unity Software Suite for hearing assessment and calibration.

It is supplied as a non-sterile, reusable system intended for use in clinical settings such as audiology or ENT practices. The device received FDA 510(k) clearance (K952098) as substantially equivalent to a predicate device and is classified under regulation number 874.3310 with product code ETW.

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