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510(k) K830034

MODEL EM-2 BIOELECTRIC PROCESSOR by Myo-Tronics Research, Inc. — Product Code KZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1983
Date Received
January 7, 1983
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 Research, Inc.

  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K842224 — BNS 40 (November 19, 1984)
  • K833132 — MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (February 10, 1984)
  • K831364 — TESTCORP RA (May 27, 1983)
  • K813533 — ELECTRIC MUSCLE STIMULATOR (March 5, 1982)
  • K810528 — MODEL EM-IR (March 31, 1981)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

Other clearances for product code KZM

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  • 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)