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FDA 510(k)

ENDEARE BREAST PUMP

K-Number: K081932 · 2009-01-22

ApplicantHygeia Medical, Inc.
Decision Date2009-01-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDEARE BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia Medical, Inc.. It received FDA 510(k) clearance on 2009-01-22 under 510(k) number K081932. 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 ENDEARE BREAST PUMP?

ENDEARE BREAST PUMP is a medical device that received FDA 510(k) clearance on 2009-01-22. The listed applicant is Hygeia Medical, Inc.. The 510(k) number is K081932.

When did ENDEARE BREAST PUMP receive FDA 510(k) clearance?

ENDEARE BREAST PUMP received FDA 510(k) clearance on 2009-01-22, under 510(k) number K081932.

Who is the listed applicant for ENDEARE BREAST PUMP?

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

What is the FDA product code for ENDEARE BREAST PUMP?

The FDA product code for ENDEARE BREAST PUMP is HGX.

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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.

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH 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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