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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K003542
Device Name PREAMP CABLE, MODEL B400-1011PA
Applicant
BETA BIOMED SERVICES, INC.
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact EJ Smith
Correspondent
BETA BIOMED SERVICES, INC.
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact EJ Smith
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/17/2000
Decision Date 04/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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