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FDA 510(k)

EGNELL-LACT B BATTERY-OPERATED BREAST PUMP

K-Number: K844307 · 1985-02-04

ApplicantEgnell, Inc.
Decision Date1985-02-04
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EGNELL-LACT B BATTERY-OPERATED BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1985-02-04 under 510(k) number K844307. 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 EGNELL-LACT B BATTERY-OPERATED BREAST PUMP?

EGNELL-LACT B BATTERY-OPERATED BREAST PUMP is a medical device that received FDA 510(k) clearance on 1985-02-04. The listed applicant is Egnell, Inc.. The 510(k) number is K844307.

When did EGNELL-LACT B BATTERY-OPERATED BREAST PUMP receive FDA 510(k) clearance?

EGNELL-LACT B BATTERY-OPERATED BREAST PUMP received FDA 510(k) clearance on 1985-02-04, under 510(k) number K844307.

Who is the listed applicant for EGNELL-LACT B BATTERY-OPERATED BREAST PUMP?

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

What is the FDA product code for EGNELL-LACT B BATTERY-OPERATED BREAST PUMP?

The FDA product code for EGNELL-LACT B BATTERY-OPERATED BREAST PUMP is HGX.

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Other records listing Egnell, 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.

K853909EGNELL UNIVERSAL SUCTION PUMPK853917EGNELL COMPACT SUCTION PUMPK840526AMETHERMK834335AMEDA PHOTOTHERAPY LAMP FOR NEWBORNK832637AMEDA NEONATAL RESUSCITATION UNIT-K813312UNIVERSAL SUCTION PUMP TYPE EUS

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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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