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510(k) K850643

HR/BVP 100T HEART RATE MONITOR by Thought Technology , Ltd. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1985
Date Received
February 19, 1985
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

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  • K053266 — MYOTRAC INFINITI (December 29, 2005)
  • K925681 — MYOTRAC2D/CS (September 29, 1995)
  • K935213 — INCONTROL (May 11, 1995)
  • K932149 — THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE (May 11, 1995)
  • K915858 — MYOTRAC2 (September 9, 1992)
  • K915859 — MYOTRAC/S, MYODAC/S (September 9, 1992)
  • K913898 — MYOTRAC+/S, MYODAC+/S (March 26, 1992)

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  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
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