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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 K905310
Device Name MINIOX V PULSE OXIMETER
Applicant
CATALYST RESEARCH CORP.
3706 CRONDALL LN.
OWINGS MILLS,  MD  21117
Applicant Contact DEVAN WOLF
Correspondent
CATALYST RESEARCH CORP.
3706 CRONDALL LN.
OWINGS MILLS,  MD  21117
Correspondent Contact DEVAN WOLF
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/28/1990
Decision Date 05/28/1991
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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