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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Flow, Cerebral, Thermal Diffusion
510(k) Number K850657
Device Name THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
Applicant
Flowtronics, Inc.
10250 N. 19th Ave., Suite B
Phoenix,  AZ  85021
Applicant Contact MARGARET A SULLIVAN
Correspondent
Flowtronics, Inc.
10250 N. 19th Ave., Suite B
Phoenix,  AZ  85021
Correspondent Contact MARGARET A SULLIVAN
Classification Product Code
LME  
Date Received01/28/1985
Decision Date 02/22/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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