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FDA 510(k)

IONTOPATCH

K-Number: K992708 · 2000-02-01

ApplicantBirch Point Medical, Inc.
Decision Date2000-02-01
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IONTOPATCH is the device name listed in this FDA 510(k) record. The listed applicant is Birch Point Medical, Inc.. It received FDA 510(k) clearance on 2000-02-01 under 510(k) number K992708. 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 IONTOPATCH?

IONTOPATCH is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Birch Point Medical, Inc.. The 510(k) number is K992708.

When did IONTOPATCH receive FDA 510(k) clearance?

IONTOPATCH received FDA 510(k) clearance on 2000-02-01, under 510(k) number K992708.

Who is the listed applicant for IONTOPATCH?

The FDA 510(k) record lists Birch Point Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IONTOPATCH?

The FDA product code for IONTOPATCH is EGJ.

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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.

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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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