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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 K882547
Device Name VARITEST
Applicant
Eureka AB
Fredsforsstigen 22
S-161 70 Bromma
Stockholm, Sweden,  SE
Applicant Contact H-O PILZ
Correspondent
Eureka AB
Fredsforsstigen 22
S-161 70 Bromma
Stockholm, Sweden,  SE
Correspondent Contact H-O PILZ
Regulation Number870.2780
Classification Product Code
JOM  
Date Received06/21/1988
Decision Date 11/03/1988
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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