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FDA 510(k)

FLOWpresso

K-Number: K223729 · 2023-12-21

ApplicantMedella Health Limited
Decision Date2023-12-21
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLOWpresso is a medical device manufactured by Medella Health Limited. It received FDA 510(k) clearance on 2023-12-21 under approval number K223729. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWpresso?

FLOWpresso is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Medella Health Limited. The 510(k) number is K223729.

When was FLOWpresso approved by the FDA?

FLOWpresso received FDA 510(k) clearance on 2023-12-21, under approval number K223729.

What company makes FLOWpresso?

FLOWpresso is manufactured by Medella Health Limited.

What is the FDA product code for FLOWpresso?

The FDA product code for FLOWpresso is IRP.

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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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