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FDA 510(k)

SINGLE HANDED BREAST PUMP

K-Number: K941112 · 1995-01-30

ApplicantMacneil Baby Care , Ltd.
Decision Date1995-01-30
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SINGLE HANDED BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Macneil Baby Care , Ltd.. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K941112. 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 SINGLE HANDED BREAST PUMP?

SINGLE HANDED BREAST PUMP is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Macneil Baby Care , Ltd.. The 510(k) number is K941112.

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

SINGLE HANDED BREAST PUMP received FDA 510(k) clearance on 1995-01-30, under 510(k) number K941112.

Who is the listed applicant for SINGLE HANDED BREAST PUMP?

The FDA 510(k) record lists Macneil Baby Care , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE HANDED BREAST PUMP?

The FDA product code for SINGLE HANDED 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

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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