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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 K952172
Device Name HOTMAN
Applicant
Hemo Sapiens, Inc.
19211 Edgehill Dr.
Irvine,  CA  92612
Applicant Contact B. BO SRAMEK
Correspondent
Hemo Sapiens, Inc.
19211 Edgehill Dr.
Irvine,  CA  92612
Correspondent Contact B. BO SRAMEK
Regulation Number870.2770
Classification Product Code
DSB  
Date Received05/08/1995
Decision Date 06/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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