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FDA 510(k)

Willow Wearable Breast Pump 2.0

K-Number: K191577 · 2019-09-06

ApplicantExploramed Nc7, Inc.
Decision Date2019-09-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Willow Wearable Breast Pump 2.0 is a medical device manufactured by Exploramed Nc7, Inc.. It received FDA 510(k) clearance on 2019-09-06 under approval number K191577. 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 Willow Wearable Breast Pump 2.0?

Willow Wearable Breast Pump 2.0 is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Exploramed Nc7, Inc.. The 510(k) number is K191577.

When was Willow Wearable Breast Pump 2.0 approved by the FDA?

Willow Wearable Breast Pump 2.0 received FDA 510(k) clearance on 2019-09-06, under approval number K191577.

What company makes Willow Wearable Breast Pump 2.0?

Willow Wearable Breast Pump 2.0 is manufactured by Exploramed Nc7, Inc..

What is the FDA product code for Willow Wearable Breast Pump 2.0?

The FDA product code for Willow Wearable Breast Pump 2.0 is HGX.

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Other Devices by Exploramed Nc7, Inc.

K161266Athena Breast Pump

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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