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FDA 510(k)

Perifit Pump

K-Number: K231785 · 2024-01-26

ApplicantX6 Innovations
Decision Date2024-01-26
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Perifit Pump is the device name listed in this FDA 510(k) record. The listed applicant is X6 Innovations. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K231785. 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 Perifit Pump?

Perifit Pump is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is X6 Innovations. The 510(k) number is K231785.

When did Perifit Pump receive FDA 510(k) clearance?

Perifit Pump received FDA 510(k) clearance on 2024-01-26, under 510(k) number K231785.

Who is the listed applicant for Perifit Pump?

The FDA 510(k) record lists X6 Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perifit Pump?

The FDA product code for Perifit Pump is HGX.

Other records listing X6 Innovations 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.

K231780Perifit Care+K221476Perifit

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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