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510(k) K810528

MODEL EM-IR by Myo-Tronics Research, Inc. — Product Code KZM

K810528 is an FDA 510(k) premarket notification submitted by Myo-Tronics Research, Inc. for the device "MODEL EM-IR". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. Myo-Tronics Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1981
Date Received
February 26, 1981
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)
  • K830034 — MODEL EM-2 BIOELECTRIC PROCESSOR (February 9, 1983)
  • K813533 — ELECTRIC MUSCLE STIMULATOR (March 5, 1982)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

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