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510(k) K970116

ESG-1 ELECTROSONOGRAM (ESG-1) by Myo-Tronics, Inc. — Product Code NFQ

K970116 is an FDA 510(k) premarket notification submitted by Myo-Tronics, Inc. for the device "ESG-1 ELECTROSONOGRAM (ESG-1)". The FDA issued a decision of Substantially Equivalent on April 2, 1997. The device falls under product code NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds), a Class I device regulated under 21 CFR 872.2050. Myo-Tronics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1997
Date Received
January 13, 1997
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 by Myo-Tronics, Inc.

  • K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (December 9, 1994)
  • K922270 — PHYSIOTECH 4000 OR NORODYN 8000 (September 2, 1994)
  • K922456 — K6-I DIAGNOSTIC SYSTEM (June 9, 1994)
  • K921919 — MS-100 MYO-SCANNER OR MS-100 EMG SCANNER (January 7, 1993)
  • K905449 — ELECTROSONOGRAM ESG-1 (April 26, 1991)

Other clearances for product code NFQ

  • K905657 — SONOPAK/QS, SONOPAK (May 15, 1991)
  • K905449 — ELECTROSONOGRAM ESG-1 (April 26, 1991)
  • K862286 — ARTHROPHONOMETER (January 7, 1987)

FDA data resources