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FDA 510(k)

Ameda Pearl Electric Breast Pump

K-Number: K221576 · 2022-10-12

ApplicantAmeda, Inc.
Decision Date2022-10-12
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ameda Pearl Electric Breast Pump is a medical device manufactured by Ameda, Inc.. It received FDA 510(k) clearance on 2022-10-12 under approval number K221576. 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 Ameda Pearl Electric Breast Pump?

Ameda Pearl Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Ameda, Inc.. The 510(k) number is K221576.

When was Ameda Pearl Electric Breast Pump approved by the FDA?

Ameda Pearl Electric Breast Pump received FDA 510(k) clearance on 2022-10-12, under approval number K221576.

What company makes Ameda Pearl Electric Breast Pump?

Ameda Pearl Electric Breast Pump is manufactured by Ameda, Inc..

What is the FDA product code for Ameda Pearl Electric Breast Pump?

The FDA product code for Ameda Pearl Electric Breast Pump is HGX.

Related Clinical Trials

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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.