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FDA 510(k)

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101

K-Number: K052047 · 2005-09-22

ApplicantAvent America, Inc.
Decision Date2005-09-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 is the device name listed in this FDA 510(k) record. The listed applicant is Avent America, Inc.. It received FDA 510(k) clearance on 2005-09-22 under 510(k) number K052047. 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 ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101?

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 is a medical device that received FDA 510(k) clearance on 2005-09-22. The listed applicant is Avent America, Inc.. The 510(k) number is K052047.

When did ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 receive FDA 510(k) clearance?

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 received FDA 510(k) clearance on 2005-09-22, under 510(k) number K052047.

Who is the listed applicant for ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101?

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

What is the FDA product code for ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101?

The FDA product code for ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 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 Avent America, 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.

K051413ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100K952035NIPLETTEK944117AVENT NIPPLE SHIELD

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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