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FDA 510(k)

MEDELA ELECTRIC BREAST PUMP

K-Number: K801862 · 1980-10-23

ApplicantMedela, Inc.
Decision Date1980-10-23
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDELA ELECTRIC BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K801862. 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 MEDELA ELECTRIC BREAST PUMP?

MEDELA ELECTRIC BREAST PUMP is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Medela, Inc.. The 510(k) number is K801862.

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

MEDELA ELECTRIC BREAST PUMP received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801862.

Who is the listed applicant for MEDELA ELECTRIC BREAST PUMP?

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

What is the FDA product code for MEDELA ELECTRIC BREAST PUMP?

The FDA product code for MEDELA ELECTRIC BREAST PUMP is HGX.

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Other records listing Medela, 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.

K161811Medela Low Dose Enteral SyringeK161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailK031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMPK020518MEDELA SYMPHONY BREAST PUMP, MODEL 024K984589PHOTOTHERAPY LAMPK983552BASIC, MEDIAN, DOMINANT, AND VARIO

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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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