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FDA 510(k)

IontoDC

K-Number: K170291 · 2017-05-01

ApplicantSoterix Medical, Inc.
Decision Date2017-05-01
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IontoDC is a medical device manufactured by Soterix Medical, Inc.. It received FDA 510(k) clearance on 2017-05-01 under approval number K170291. 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 IontoDC?

IontoDC is a medical device that received FDA 510(k) clearance on 2017-05-01. It is manufactured by Soterix Medical, Inc.. The 510(k) number is K170291.

When was IontoDC approved by the FDA?

IontoDC received FDA 510(k) clearance on 2017-05-01, under approval number K170291.

What company makes IontoDC?

IontoDC is manufactured by Soterix Medical, Inc..

What is the FDA product code for IontoDC?

The FDA product code for IontoDC is EGJ.

Other Devices by Soterix Medical, Inc.

K191422Neural Navigator K192823MEGA-TMS K233751Milieve (YPS-301BD) K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) K251653SPRY TMS Therapy System (0550)

Related Devices (Code: EGJ)

K170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development K191436SaalioSaalmann Medical GmbH & Co. KG K192749DermadryDermadry Laboratories, Inc. K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd. K241267Hidroxa SE30Hidroxa Medical AB K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.

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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