FDA 510(k)

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

Numéro K : K182749 · 2019-06-12

DemandeurLansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.

Date de décision2019-06-12

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Source officielle

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