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510(k) K905657

SONOPAK/QS, SONOPAK by Bioresearch — Product Code NFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
December 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Dental Sonography, For Monitoring Jaw Sounds
Device Class
Class I
Regulation Number
872.2050
Review Panel
DE
Submission Type

Other clearances for product code NFQ

  • K970116 — ESG-1 ELECTROSONOGRAM (ESG-1) (April 2, 1997)
  • K905449 — ELECTROSONOGRAM ESG-1 (April 26, 1991)
  • K862286 — ARTHROPHONOMETER (January 7, 1987)