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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 K901774
Device Name HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
Applicant
MENNEN MEDICAL, INC.
10123 MAIN ST.
CLARENCE,  NY  14031
Applicant Contact G WHITEHEAD
Correspondent
MENNEN MEDICAL, INC.
10123 MAIN ST.
CLARENCE,  NY  14031
Correspondent Contact G WHITEHEAD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/19/1990
Decision Date 05/22/1990
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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