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FDA 510(k)

Fit Pro Breast Pump

K-Number: K212955 · 2022-03-15

ApplicantHygeia II Medical Group, Inc.
Decision Date2022-03-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fit Pro Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia II Medical Group, Inc.. It received FDA 510(k) clearance on 2022-03-15 under 510(k) number K212955. 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 Fit Pro Breast Pump?

Fit Pro Breast Pump is a medical device that received FDA 510(k) clearance on 2022-03-15. The listed applicant is Hygeia II Medical Group, Inc.. The 510(k) number is K212955.

When did Fit Pro Breast Pump receive FDA 510(k) clearance?

Fit Pro Breast Pump received FDA 510(k) clearance on 2022-03-15, under 510(k) number K212955.

Who is the listed applicant for Fit Pro Breast Pump?

The FDA 510(k) record lists Hygeia II Medical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fit Pro Breast Pump?

The FDA product code for Fit Pro Breast Pump is HGX.

Other records listing Hygeia II Medical Group, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233136Hygeia Express Powered Breast PumpK200406Evolve Breast PumpK190465Evolve Breast Pump

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

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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