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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 K041647
Device Name FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
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 Received06/17/2004
Decision Date 09/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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