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FDA 510(k)

GCE704 Breast Pump

K-Number: K172842 · 2018-06-18

ApplicantGlobalcare
Decision Date2018-06-18
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GCE704 Breast Pump is a medical device manufactured by Globalcare. It received FDA 510(k) clearance on 2018-06-18 under approval number K172842. 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 GCE704 Breast Pump?

GCE704 Breast Pump is a medical device that received FDA 510(k) clearance on 2018-06-18. It is manufactured by Globalcare. The 510(k) number is K172842.

When was GCE704 Breast Pump approved by the FDA?

GCE704 Breast Pump received FDA 510(k) clearance on 2018-06-18, under approval number K172842.

What company makes GCE704 Breast Pump?

GCE704 Breast Pump is manufactured by Globalcare.

What is the FDA product code for GCE704 Breast Pump?

The FDA product code for GCE704 Breast Pump is HGX.

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. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

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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