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K233913

Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)

510(k) number
K233913
Device name
Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
Applicant
Aoj Health Technology Co., Ltd. CN
Product code
HGX — Pump, Breast, Powered
Decision date
2024-05-14
Date received
2023-12-12
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233913
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.