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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K222573
Device Name imani i2Plus Breast Pump
Applicant
imani Co.
147, Hwasan-ro, Idong-eup, Cheoin-gu
Yongin-si,  CN 17135
Applicant Contact Hyo-Soon Hwang
Correspondent
Global Medical Standard Consulting Co., Ltd.
34, Sangamsan-ro, Mapo-gu
Seoul,  KR 03909
Correspondent Contact Kyung Jin Lee
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/25/2022
Decision Date 03/03/2023
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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