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510(k) K921919

MS-100 MYO-SCANNER OR MS-100 EMG SCANNER by Myo-Tronics, Inc. — Product Code KZM

K921919 is an FDA 510(k) premarket notification submitted by Myo-Tronics, Inc. for the device "MS-100 MYO-SCANNER OR MS-100 EMG SCANNER". The FDA issued a decision of Substantially Equivalent on January 7, 1993. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. Myo-Tronics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1993
Date Received
April 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Muscle Monitoring
Device Class
Class II
Regulation Number
890.1375
Review Panel
DE
Submission Type

Other clearances by Myo-Tronics, Inc.

  • K970116 — ESG-1 ELECTROSONOGRAM (ESG-1) (April 2, 1997)
  • 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)
  • K905449 — ELECTROSONOGRAM ESG-1 (April 26, 1991)

Other clearances for product code KZM

  • K161716 — TEETHAN 2.0 (December 21, 2016)
  • K130158 — M-SCAN (July 25, 2013)
  • K113677 — GRINDCARE MEASURE (April 5, 2012)
  • K082927 — BIOEMG III (February 6, 2009)
  • K043373 — DOLOTENS DENTAL TM 1 (September 2, 2005)
  • K030869 — BITESTRIP (May 14, 2004)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (September 10, 1999)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)

FDA data resources