FDA 510(k)

Powered Breast Pump (Models 7V and 7X)

K-Number: K211016 · 2022-06-29

Decision Date2022-06-29

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Powered Breast Pump (Models 7V and 7X) is a medical device manufactured by Haenim Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under approval number K211016. 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 Powered Breast Pump (Models 7V and 7X)?

Powered Breast Pump (Models 7V and 7X) is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Haenim Co., Ltd.. The 510(k) number is K211016.

When was Powered Breast Pump (Models 7V and 7X) approved by the FDA?

Powered Breast Pump (Models 7V and 7X) received FDA 510(k) clearance on 2022-06-29, under approval number K211016.

What company makes Powered Breast Pump (Models 7V and 7X)?

Powered Breast Pump (Models 7V and 7X) is manufactured by Haenim Co., Ltd..

What is the FDA product code for Powered Breast Pump (Models 7V and 7X)?

The FDA product code for Powered Breast Pump (Models 7V and 7X) is HGX.

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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

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