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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 K000814
Device Name FINGER PULSE METER
Applicant
BHS INTL., INC.
2431 CROFTON LN., SUITE 9
CROFTON,  MD  21114
Applicant Contact CHRIS REDDING
Correspondent
BHS INTL., INC.
2431 CROFTON LN., SUITE 9
CROFTON,  MD  21114
Correspondent Contact CHRIS REDDING
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/13/2000
Decision Date 03/29/2001
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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