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510(k) K943607

INTERACOUSTICS HEARING AID ANALYZER MS 40 by Precision Acoustics Ind., Inc. — Product Code ETW

K943607 is an FDA 510(k) premarket notification submitted by Precision Acoustics Ind., Inc. for the device "INTERACOUSTICS HEARING AID ANALYZER MS 40". The FDA issued a decision of Substantially Equivalent on September 23, 1994. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Precision Acoustics Ind., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1994
Date Received
July 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Precision Acoustics Ind., Inc.

  • K941920 — INTERACOUSTICS CLINICAL AUDIOMETER (September 16, 1994)
  • K942007 — INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 (August 24, 1994)
  • K943066 — INTERACOUSTICS COMPUTER AUDIOMETER BA 20 (August 24, 1994)
  • K942008 — INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER (August 24, 1994)
  • K943065 — INTERACOUSTICS CLINICAL AUDIOMETER (August 17, 1994)
  • K942006 — INTERACOUSTICS DIAGNOSTIC AUDIOMETER (June 20, 1994)
  • K941848 — INTERACOUSTICS. HEARING AID ANALYZER (May 23, 1994)
  • K930260 — ACOUSTIC ANALYZER AA30 (July 13, 1993)

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)
  • K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (June 5, 2007)
  • 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)

FDA data resources