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FDA 510(k)

Athena Breast Pump

K-Number: K161266 · 2016-08-11

ApplicantExploramed Nc7, Inc.
Decision Date2016-08-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Athena Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Exploramed Nc7, Inc.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K161266. 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 Athena Breast Pump?

Athena Breast Pump is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Exploramed Nc7, Inc.. The 510(k) number is K161266.

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

Athena Breast Pump received FDA 510(k) clearance on 2016-08-11, under 510(k) number K161266.

Who is the listed applicant for Athena Breast Pump?

The FDA 510(k) record lists Exploramed Nc7, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Athena Breast Pump?

The FDA product code for Athena Breast Pump is HGX.

Other records listing Exploramed Nc7, 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.

K191577Willow Wearable Breast Pump 2.0

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

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

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