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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K852378
Device Name LIGHT REFLECTION RHEOGRAPHY
Applicant
Hemodynamics, Inc.
1515 N. Federal Hwy.
Boca Raton,  FL  33432
Applicant Contact EUGENE BROWN
Correspondent
Hemodynamics, Inc.
1515 N. Federal Hwy.
Boca Raton,  FL  33432
Correspondent Contact EUGENE BROWN
Regulation Number870.2770
Classification Product Code
DSB  
Date Received06/05/1985
Decision Date 06/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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