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510(k) K071462

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) by Siemens Hearing Instruments, Inc. — Product Code ETW

K071462 is an FDA 510(k) premarket notification submitted by Siemens Hearing Instruments, Inc. for the device "UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)". The FDA issued a decision of Substantially Equivalent on June 5, 2007. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Siemens Hearing Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2007
Date Received
May 25, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

Other clearances by Siemens Hearing Instruments, Inc.

  • K011364 — CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) (June 7, 2001)
  • K011366 — CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (June 1, 2001)
  • K003559 — TCI (TINNITUS CONTROL INSTRUMENT) (April 26, 2001)
  • K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (April 24, 2001)
  • K972998 — PRISMA (September 5, 1997)
  • K962170 — SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP (July 25, 1996)
  • K952940 — PERSONAL PROGRAMMER 2000 (July 26, 1995)
  • K951828 — FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (June 30, 1995)
  • K952263 — PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT (June 5, 1995)
  • K951896 — INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARIN (May 30, 1995)

Other clearances for product code ETW

  • K122028 — AURICAL HIT (October 23, 2012)
  • K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT (April 19, 2012)
  • K110286 — GN OTOMETRICS TYPE 1053 FREEFIT (April 28, 2011)
  • K093006 — FONIX ,MODEL 8000 (December 30, 2009)
  • K061104 — SPEECHLINK 100 TYPE 1053 (May 3, 2006)
  • K050496 — REM440 (April 29, 2005)
  • K041853 — OTOGRAM (September 3, 2004)
  • K022510 — FONIX, MODEL 7000 (August 27, 2002)
  • K012306 — AUDIOSCAN VERIFIT, MODEL VF-1 (September 21, 2001)
  • K980377 — FONIX FP35 HEARING AID ANALYZER (March 18, 1998)

FDA data resources