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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 K873896
Device Name SIMED S-100 PULSE OXIMETER
Applicant
Simed
11818 Northcreek Pkwy. N.
Bothell,  WA  98011
Applicant Contact LAU, MD
Correspondent
Simed
11818 Northcreek Pkwy. N.
Bothell,  WA  98011
Correspondent Contact LAU, MD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/02/1987
Decision Date 03/07/1988
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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