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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, biofeedback
510(k) Number K850643
Device Name HR/BVP 100T HEART RATE MONITOR
Applicant
THOUGHT TECHNOLOGY LTD.
2180 BELGRAVE AVE.
MONTREAL, QUEBEC,  CA H4A 2L8
Applicant Contact HAL K MYERS
Correspondent
THOUGHT TECHNOLOGY LTD.
2180 BELGRAVE AVE.
MONTREAL, QUEBEC,  CA H4A 2L8
Correspondent Contact HAL K MYERS
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/19/1985
Decision Date 05/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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