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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K801291
Device Name EC-4 PLETHYSMOGRAPH
Applicant
D. E. Hokanson, Inc.
WA 
Correspondent
D. E. Hokanson, Inc.
WA 
Regulation Number870.2780
Classification Product Code
JOM  
Date Received06/02/1980
Decision Date 07/08/1980
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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