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FDA 510(k)

Smartpump 3.0 Double Electric Breast Pump

K-Number: K222726 · 2022-12-23

ApplicantLansinoh Laboratories
Decision Date2022-12-23
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Smartpump 3.0 Double Electric Breast Pump is a medical device manufactured by Lansinoh Laboratories. It received FDA 510(k) clearance on 2022-12-23 under approval number K222726. 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 Smartpump 3.0 Double Electric Breast Pump?

Smartpump 3.0 Double Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Lansinoh Laboratories. The 510(k) number is K222726.

When was Smartpump 3.0 Double Electric Breast Pump approved by the FDA?

Smartpump 3.0 Double Electric Breast Pump received FDA 510(k) clearance on 2022-12-23, under approval number K222726.

What company makes Smartpump 3.0 Double Electric Breast Pump?

Smartpump 3.0 Double Electric Breast Pump is manufactured by Lansinoh Laboratories.

What is the FDA product code for Smartpump 3.0 Double Electric Breast Pump?

The FDA product code for Smartpump 3.0 Double Electric Breast Pump is HGX.

Related Clinical Trials

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Other Devices by Lansinoh Laboratories

K230469Compact Wearable 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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