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FDA 510(k)

MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP

K-Number: K081463 · 2009-02-06

ApplicantMedel S.P.A.
Decision Date2009-02-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Medel S.P.A.. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K081463. 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 MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP?

MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Medel S.P.A.. The 510(k) number is K081463.

When did MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP receive FDA 510(k) clearance?

MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP received FDA 510(k) clearance on 2009-02-06, under 510(k) number K081463.

Who is the listed applicant for MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP?

The FDA 510(k) record lists Medel S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP?

The FDA product code for MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP is HGX.

Related Clinical Trials

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.

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Other records listing Medel S.P.A. 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.

K072494AG-CLASSICK063103AG-EDGE, MODEL 91200K060404AG-PLUS, MODEL 91210

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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