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510(k) K231595

Electric Breast Pump by Shenzhen Changkun Technology Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
June 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Shenzhen Changkun Technology Co., Ltd.

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  • K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (June 17, 2020)

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