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FDA 510(k)

SIMPLISSE ELECTRIC BREASTFEEDING COMPANION

K-Number: K093648 · 2010-07-14

ApplicantSimplisse, Inc.
Decision Date2010-07-14
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SIMPLISSE ELECTRIC BREASTFEEDING COMPANION is the device name listed in this FDA 510(k) record. The listed applicant is Simplisse, Inc.. It received FDA 510(k) clearance on 2010-07-14 under 510(k) number K093648. 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 SIMPLISSE ELECTRIC BREASTFEEDING COMPANION?

SIMPLISSE ELECTRIC BREASTFEEDING COMPANION is a medical device that received FDA 510(k) clearance on 2010-07-14. The listed applicant is Simplisse, Inc.. The 510(k) number is K093648.

When did SIMPLISSE ELECTRIC BREASTFEEDING COMPANION receive FDA 510(k) clearance?

SIMPLISSE ELECTRIC BREASTFEEDING COMPANION received FDA 510(k) clearance on 2010-07-14, under 510(k) number K093648.

Who is the listed applicant for SIMPLISSE ELECTRIC BREASTFEEDING COMPANION?

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

What is the FDA product code for SIMPLISSE ELECTRIC BREASTFEEDING COMPANION?

The FDA product code for SIMPLISSE ELECTRIC BREASTFEEDING COMPANION 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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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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