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510(k) K992694

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I by Myotronics-Noromed, Inc. — Product Code KZM

K992694 is an FDA 510(k) premarket notification submitted by Myotronics-Noromed, Inc. for the device "MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I". The FDA issued a decision of Substantially Equivalent on September 10, 1999. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. Myotronics-Noromed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1999
Date Received
August 12, 1999
Clearance Type
Special
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 Myotronics-Noromed, Inc.

  • K111687 — EMG SYSTEM (September 29, 2011)
  • K040400 — MYO-TRODE SG DISPOSABLE ELECTRODE (July 20, 2004)
  • K031998 — MODEL J-5 MVO-MONITOR (July 24, 2003)
  • K013399 — MODEL MES-9000/EMG SYSTEM (November 13, 2001)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992439 — NORODYN 8000 SEMG SYSTEM, ND-8000 (August 13, 1999)

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)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (December 9, 1994)

FDA data resources