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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 a medical device manufactured by Philips Consumer Lifestyle - Innovation Site Eindhoven. It received FDA 510(k) clearance on 2016-08-29 under approval 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. It is manufactured by Philips Consumer Lifestyle - Innovation Site Eindhoven. The 510(k) number is K161532.

When was Philips Avent Comfort Single/Twin Electric Breast Pump approved by the FDA?

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

What company makes Philips Avent Comfort Single/Twin Electric Breast Pump?

Philips Avent Comfort Single/Twin Electric Breast Pump is manufactured by Philips Consumer Lifestyle - Innovation Site Eindhoven.

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.

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Other Devices by Philips Consumer Lifestyle - Innovation Site Eindhoven

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

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc. K150476Spectra S1Plus and Spectra S2 PlusUzinmedicare Co.

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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