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FDA 510(k)

Philips Avent Comfort Single/Twin Electric Breast Pump

K-Number: K161532 · 2016-08-29

ApplicantPhilips Consumer Lifestyle - Innovation Site Eindhoven
Decision Date2016-08-29
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Philips Avent Comfort Single/Twin Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161532. 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 Philips Avent Comfort Single/Twin Electric Breast Pump?

Philips Avent Comfort Single/Twin Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. The 510(k) number is K161532.

When did Philips Avent Comfort Single/Twin Electric Breast Pump receive FDA 510(k) clearance?

Philips Avent Comfort Single/Twin Electric Breast Pump received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161532.

Who is the listed applicant for Philips Avent Comfort Single/Twin Electric Breast Pump?

The FDA 510(k) record lists Philips Consumer Lifestyle - Innovation Site Eindhoven as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Avent Comfort Single/Twin Electric Breast Pump?

The FDA product code for Philips Avent Comfort Single/Twin Electric Breast Pump is HGX.

Other records listing Philips Consumer Lifestyle - Innovation Site Eindhoven as applicant

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.

K203383Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62K201381Philips Avent Single/Double electric breast pump Advanced

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

View on FDA Database →

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

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