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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K101988
Device Name HEAL FORCE CO2 INCUBATOR
Applicant
SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD
77325 JOYCE WAY
ECHO,  OR  97826
Applicant Contact CHARLES MACK
Correspondent
SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD
77325 JOYCE WAY
ECHO,  OR  97826
Correspondent Contact CHARLES MACK
Regulation Number884.6120
Classification Product Code
MQG  
Date Received07/14/2010
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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