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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 K141105
Device Name PULSE OXIMETER
Applicant
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
M8-613, NO.8, LUTIAN RD. CHANGSHA NATIONAL
HI-TECH INDUST DEVELOPMENT ZONE
CHANGSHA, HUNAN,  CN 410205
Applicant Contact LI ZHANG
Correspondent
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
M8-613, NO.8, LUTIAN RD. CHANGSHA NATIONAL
HI-TECH INDUST DEVELOPMENT ZONE
CHANGSHA, HUNAN,  CN 410205
Correspondent Contact LI ZHANG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/29/2014
Decision Date 12/04/2014
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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