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510(k) K942006

INTERACOUSTICS DIAGNOSTIC AUDIOMETER by Precision Acoustics Ind., Inc. — Product Code EWO

K942006 is an FDA 510(k) premarket notification submitted by Precision Acoustics Ind., Inc. for the device "INTERACOUSTICS DIAGNOSTIC AUDIOMETER". The FDA issued a decision of Substantially Equivalent on June 20, 1994. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Precision Acoustics Ind., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1994
Date Received
April 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Precision Acoustics Ind., Inc.

  • K943607 — INTERACOUSTICS HEARING AID ANALYZER MS 40 (September 23, 1994)
  • K941920 — INTERACOUSTICS CLINICAL AUDIOMETER (September 16, 1994)
  • K943066 — INTERACOUSTICS COMPUTER AUDIOMETER BA 20 (August 24, 1994)
  • K942008 — INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER (August 24, 1994)
  • K942007 — INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26 (August 24, 1994)
  • K943065 — INTERACOUSTICS CLINICAL AUDIOMETER (August 17, 1994)
  • K941848 — INTERACOUSTICS. HEARING AID ANALYZER (May 23, 1994)
  • K930260 — ACOUSTIC ANALYZER AA30 (July 13, 1993)

Other clearances for product code EWO

  • K234095 — OtoNova/OtoNova Pro (June 21, 2024)
  • K240430 — Otoport Pro (March 15, 2024)
  • K231545 — hearOAE (October 27, 2023)
  • K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, Na (June 22, 2022)
  • K191372 — Lyra (July 15, 2019)
  • K180287 — GSI Corti (May 11, 2018)
  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)

FDA data resources