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510(k) K963681

CCA-100 (MODIFIED) by Benson Medical Instruments Co. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1996
Date Received
July 11, 1996
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 Benson Medical Instruments Co.

  • K123896 — CCS-200 SPIROMETER (September 10, 2013)
  • K982441 — CCA-220 (October 9, 1998)
  • K981439 — CCA-200 (June 15, 1998)
  • K924652 — BENSON CCA100 (April 9, 1993)

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  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K171506 — Easyscreen (August 29, 2017)
  • K151025 — iHearTest (December 29, 2015)