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FDA 510(k)

SIMPLYGO BREAST PUMP

K-Number: K102600 · 2010-12-22

ApplicantEvenflo Company, Inc.
Decision Date2010-12-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SIMPLYGO BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Evenflo Company, Inc.. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K102600. 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 SIMPLYGO BREAST PUMP?

SIMPLYGO BREAST PUMP is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Evenflo Company, Inc.. The 510(k) number is K102600.

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

SIMPLYGO BREAST PUMP received FDA 510(k) clearance on 2010-12-22, under 510(k) number K102600.

Who is the listed applicant for SIMPLYGO BREAST PUMP?

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

What is the FDA product code for SIMPLYGO BREAST PUMP?

The FDA product code for SIMPLYGO BREAST PUMP is HGX.

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Other records listing Evenflo Company, 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.

K100435AMEDA PLATINUM BREAST PUMPK092770SIMPLYGO HANDS FREE BREAST PUMPK082307EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KITK053493BERRY FRUITY TEETHERK052909EVENFLO ELAN BREAST PUMPK022933EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

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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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