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FDA 510(k)

SPECTRA SERIES BREAST PUMP

K-Number: K093145 · 2010-08-13

ApplicantUzinmedicare Co.
Decision Date2010-08-13
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECTRA SERIES BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2010-08-13 under 510(k) number K093145. 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 SPECTRA SERIES BREAST PUMP?

SPECTRA SERIES BREAST PUMP is a medical device that received FDA 510(k) clearance on 2010-08-13. The listed applicant is Uzinmedicare Co.. The 510(k) number is K093145.

When did SPECTRA SERIES BREAST PUMP receive FDA 510(k) clearance?

SPECTRA SERIES BREAST PUMP received FDA 510(k) clearance on 2010-08-13, under 510(k) number K093145.

Who is the listed applicant for SPECTRA SERIES BREAST PUMP?

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

What is the FDA product code for SPECTRA SERIES BREAST PUMP?

The FDA product code for SPECTRA SERIES BREAST PUMP 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 Uzinmedicare Co. 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.

K210124Synergy Gold (SG) Portable (Models MM011450 and MM011460)K191109Spectra QK191208Spectra CashmereK181784Spectra S3 PlusK150476Spectra S1Plus and Spectra S2 Plus

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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