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FDA 510(k)

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

K-Number: K182749 · 2019-06-12

ApplicantLansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.
Decision Date2019-06-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K182749. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump?

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.. The 510(k) number is K182749.

When did Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump receive FDA 510(k) clearance?

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump received FDA 510(k) clearance on 2019-06-12, under 510(k) number K182749.

Who is the listed applicant for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump?

The FDA 510(k) record lists Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump?

The FDA product code for Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump is HGX.

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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