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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 K902192
Device Name MODEL MSC SA02-5000 PULSE OXIMETER
Applicant
Medical Systems Corp.
One Plz. Rd.
Greenvale,  NY  11548
Applicant Contact MARDIN VARELA
Correspondent
Medical Systems Corp.
One Plz. Rd.
Greenvale,  NY  11548
Correspondent Contact MARDIN VARELA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/16/1990
Decision Date 08/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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