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510(k) K944134

K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 by Myo-Tronics, Inc. — Product Code KZM

K944134 is an FDA 510(k) premarket notification submitted by Myo-Tronics, Inc. for the device "K6-1 DIAGNOSTIC SYSTEM VERSION 3.1". The FDA issued a decision of Substantially Equivalent on December 9, 1994. 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
December 9, 1994
Date Received
August 24, 1994
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)
  • 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 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