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FDA 510(k)

iSage Rx

K-Number: K242066 · 2024-08-21

ApplicantAmalgam Rx, Inc.
Decision Date2024-08-21
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iSage Rx is the device name listed in this FDA 510(k) record. The listed applicant is Amalgam Rx, Inc.. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K242066. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSage Rx?

iSage Rx is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Amalgam Rx, Inc.. The 510(k) number is K242066.

When did iSage Rx receive FDA 510(k) clearance?

iSage Rx received FDA 510(k) clearance on 2024-08-21, under 510(k) number K242066.

Who is the listed applicant for iSage Rx?

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

What is the FDA product code for iSage Rx?

The FDA product code for iSage Rx is NDC.

Related Devices (Code: NDC)

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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