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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 K140582
Device Name FINGERTIP PULSE OXIMETER
Applicant
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD
NANSHAN DISTRICT
SHENZHEN, GUANGDONG,  CN 518000
Applicant Contact FIELD FU
Correspondent
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD
NANSHAN DISTRICT
SHENZHEN, GUANGDONG,  CN 518000
Correspondent Contact FIELD FU
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/06/2014
Decision Date 08/28/2014
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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