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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 K041522
Device Name FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
Applicant
Elekon Industries U.S.A., Inc.
2300 Mcdermott Rd.
# 200-207
Plano,  TX  75025
Applicant Contact KRISTA OAKES
Correspondent
Elekon Industries U.S.A., Inc.
2300 Mcdermott Rd.
# 200-207
Plano,  TX  75025
Correspondent Contact KRISTA OAKES
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/07/2004
Decision Date 09/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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