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FDA 510(k)

GENTLE EXPRESSIONS ELECTRIC BREAST PUMP

K-Number: K890588 · 1989-05-16

ApplicantHealthteam
Decision Date1989-05-16
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GENTLE EXPRESSIONS ELECTRIC BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Healthteam. It received FDA 510(k) clearance on 1989-05-16 under 510(k) number K890588. 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 GENTLE EXPRESSIONS ELECTRIC BREAST PUMP?

GENTLE EXPRESSIONS ELECTRIC BREAST PUMP is a medical device that received FDA 510(k) clearance on 1989-05-16. The listed applicant is Healthteam. The 510(k) number is K890588.

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

GENTLE EXPRESSIONS ELECTRIC BREAST PUMP received FDA 510(k) clearance on 1989-05-16, under 510(k) number K890588.

Who is the listed applicant for GENTLE EXPRESSIONS ELECTRIC BREAST PUMP?

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

What is the FDA product code for GENTLE EXPRESSIONS ELECTRIC BREAST PUMP?

The FDA product code for GENTLE EXPRESSIONS ELECTRIC BREAST PUMP is HGX.

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Other records listing Healthteam 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.

K890586INFRARED DELUXEK890585INFRARED HEXK852458HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145K852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165K852653HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115K852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175

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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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