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510(k) K922270

PHYSIOTECH 4000 OR NORODYN 8000 by Myo-Tronics, Inc. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
May 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
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)
  • 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)

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  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
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