FDA 510(k)

MilkMate Breast Pump

K-Number: K223084 · 2023-03-16

Decision Date2023-03-16

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

MilkMate Breast Pump is a medical device manufactured by Milkmate Products, Inc.. It received FDA 510(k) clearance on 2023-03-16 under approval number K223084. 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 MilkMate Breast Pump?

MilkMate Breast Pump is a medical device that received FDA 510(k) clearance on 2023-03-16. It is manufactured by Milkmate Products, Inc.. The 510(k) number is K223084.

When was MilkMate Breast Pump approved by the FDA?

MilkMate Breast Pump received FDA 510(k) clearance on 2023-03-16, under approval number K223084.

What company makes MilkMate Breast Pump?

MilkMate Breast Pump is manufactured by Milkmate Products, Inc..

What is the FDA product code for MilkMate Breast Pump?

The FDA product code for MilkMate Breast Pump is HGX.

Other Devices by Milkmate Products, Inc.

K241705MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

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.