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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 the device name listed in this FDA 510(k) record. The listed applicant is Medella Health Limited. It received FDA 510(k) clearance on 2023-12-21 under 510(k) 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. The listed applicant is Medella Health Limited. The 510(k) number is K223729.

When did FLOWpresso receive FDA 510(k) clearance?

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

Who is the listed applicant for FLOWpresso?

The FDA 510(k) record lists Medella Health Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOWpresso?

The FDA product code for FLOWpresso is IRP.

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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