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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 K862798
Device Name MINIOX 100 PULSE OXIMETER
Applicant
CATALYST RESEARCH CORP.
3706 CRONDALL LN.
OWINGS MILLS,  MD  21117
Applicant Contact KENNETH J INGLE
Correspondent
CATALYST RESEARCH CORP.
3706 CRONDALL LN.
OWINGS MILLS,  MD  21117
Correspondent Contact KENNETH J INGLE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/23/1986
Decision Date 08/28/1986
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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