Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double E…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182749

by Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.

Identifiers

510(k) Number: K182749 FDA 510(k)
FDA Product Code: HGX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.5160 FDA 510(k)
Regulation Number: 884.5160 FDA 510(k)
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double E… by Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. — Class II…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K182749	Class II	Active

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Manufacturer

Manufacturer: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.

Sources (1)

FDA 510(k) K182749 24 fields · synced Jun 18, 2026