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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K844615
Device Name BIOSAMPLER
Applicant
Biotek-Caribbean
Aparado Postal 2548
Santo Domingo, Dom. Rep.,  DO
Applicant Contact FEDERICO GARCIA-GODO
Correspondent
Biotek-Caribbean
Aparado Postal 2548
Santo Domingo, Dom. Rep.,  DO
Correspondent Contact FEDERICO GARCIA-GODO
Regulation Number868.1100
Classification Product Code
CBT  
Date Received11/27/1984
Decision Date 03/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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