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FDA 510(k)

Pump In Style Advanced, Advanced Personal Double Breastpump

K-Number: K181937 · 2018-10-16

ApplicantMedela, LLC
Decision Date2018-10-16
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Pump In Style Advanced, Advanced Personal Double Breastpump is a medical device manufactured by Medela, LLC. It received FDA 510(k) clearance on 2018-10-16 under approval number K181937. 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 Pump In Style Advanced, Advanced Personal Double Breastpump?

Pump In Style Advanced, Advanced Personal Double Breastpump is a medical device that received FDA 510(k) clearance on 2018-10-16. It is manufactured by Medela, LLC. The 510(k) number is K181937.

When was Pump In Style Advanced, Advanced Personal Double Breastpump approved by the FDA?

Pump In Style Advanced, Advanced Personal Double Breastpump received FDA 510(k) clearance on 2018-10-16, under approval number K181937.

What company makes Pump In Style Advanced, Advanced Personal Double Breastpump?

Pump In Style Advanced, Advanced Personal Double Breastpump is manufactured by Medela, LLC.

What is the FDA product code for Pump In Style Advanced, Advanced Personal Double Breastpump?

The FDA product code for Pump In Style Advanced, Advanced Personal Double Breastpump is HGX.

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Other Devices by Medela, LLC

K200508Pump In Style K210759Solo, Swing Maxi K232608Duo Hands-free Breast Pump K253510Freestyle Mini Hands-free K253149Motion InBra (YM-8801) wearable breast pump K253498Pump In Style® Pro+

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Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

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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