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FDA 510(k)

Hidroxa SE30

K-Number: K241267 · 2024-10-17

ApplicantHidroxa Medical AB
Decision Date2024-10-17
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hidroxa SE30 is the device name listed in this FDA 510(k) record. The listed applicant is Hidroxa Medical AB. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K241267. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hidroxa SE30?

Hidroxa SE30 is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Hidroxa Medical AB. The 510(k) number is K241267.

When did Hidroxa SE30 receive FDA 510(k) clearance?

Hidroxa SE30 received FDA 510(k) clearance on 2024-10-17, under 510(k) number K241267.

Who is the listed applicant for Hidroxa SE30?

The FDA 510(k) record lists Hidroxa Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hidroxa SE30?

The FDA product code for Hidroxa SE30 is EGJ.

Related Devices (Code: EGJ)

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.

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KGK170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech DevelopmentK170291IontoDCSoterix Medical, 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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