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FDA 510(k)

Electric breast pump (Models: RH-228 and RH-338)

K-Number: K201903 · 2021-04-09

ApplicantCixi Ruihong Electric Appliance Co., Ltd.
Decision Date2021-04-09
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric breast pump (Models: RH-228 and RH-338) is a medical device manufactured by Cixi Ruihong Electric Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under approval number K201903. 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 Electric breast pump (Models: RH-228 and RH-338)?

Electric breast pump (Models: RH-228 and RH-338) is a medical device that received FDA 510(k) clearance on 2021-04-09. It is manufactured by Cixi Ruihong Electric Appliance Co., Ltd.. The 510(k) number is K201903.

When was Electric breast pump (Models: RH-228 and RH-338) approved by the FDA?

Electric breast pump (Models: RH-228 and RH-338) received FDA 510(k) clearance on 2021-04-09, under approval number K201903.

What company makes Electric breast pump (Models: RH-228 and RH-338)?

Electric breast pump (Models: RH-228 and RH-338) is manufactured by Cixi Ruihong Electric Appliance Co., Ltd..

What is the FDA product code for Electric breast pump (Models: RH-228 and RH-338)?

The FDA product code for Electric breast pump (Models: RH-228 and RH-338) is HGX.

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Other Devices by Cixi Ruihong Electric Appliance Co., Ltd.

K252744Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)

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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