FDA 510(k)

The Pump by Babyation

K-Number: K173699 · 2018-04-04

Decision Date2018-04-04

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

The Pump by Babyation is a medical device manufactured by Babyation, LLC. It received FDA 510(k) clearance on 2018-04-04 under approval number K173699. 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 The Pump by Babyation?

The Pump by Babyation is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Babyation, LLC. The 510(k) number is K173699.

When was The Pump by Babyation approved by the FDA?

The Pump by Babyation received FDA 510(k) clearance on 2018-04-04, under approval number K173699.

What company makes The Pump by Babyation?

The Pump by Babyation is manufactured by Babyation, LLC.

What is the FDA product code for The Pump by Babyation?

The FDA product code for The Pump by Babyation is HGX.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.