Home / 510(k) Clearances / K922456

510(k) K922456

K6-I DIAGNOSTIC SYSTEM by Myo-Tronics, Inc. — Product Code KZM

K922456 is an FDA 510(k) premarket notification submitted by Myo-Tronics, Inc. for the device "K6-I DIAGNOSTIC SYSTEM". The FDA issued a decision of SN on June 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
SN ()
Decision Date
June 9, 1994
Date Received
May 26, 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)
  • 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