SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE— 510(k) K952098

Name: FDA 510(k) clearance K952098
Creator: U.S. Food and Drug Administration
Published: 1995-05-25

Substantially Equivalent

Siemens Hearing Instruments, Inc.

FDA 510(k) clearance K952098 for SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE, Substantially Equivalent on 1995-05-25. Applicant: Siemens Hearing Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Hearing Instruments, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1995-05-04
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETW

view all

K122028 — AURICAL HIT2012-10-23
K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT2012-04-19
K110286 — GN OTOMETRICS TYPE 1053 FREEFIT2011-04-28
K093006 — FONIX ,MODEL 80002009-12-30
K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)2007-06-05

More clearances from Siemens Hearing Instruments, Inc.

view all

K011364 — CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)2001-06-07
K011366 — CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-06-01
K003559 — TCI (TINNITUS CONTROL INSTRUMENT)2001-04-26
K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-04-24
K972998 — PRISMA1997-09-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.