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510(k) K182749

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump by Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. — Product Code HGX

K182749 is an FDA 510(k) premarket notification submitted by Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. for the device "Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on Jun 12, 2019. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 12, 2019
Date Received
Sep 28, 2018
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
510(k)

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FDA data resources