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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 a medical device manufactured by Amalgam Rx, Inc.. It received FDA 510(k) clearance on 2024-08-21 under approval 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. It is manufactured by Amalgam Rx, Inc.. The 510(k) number is K242066.

When was iSage Rx approved by the FDA?

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

What company makes iSage Rx?

iSage Rx is manufactured by Amalgam Rx, Inc..

What is the FDA product code for iSage Rx?

The FDA product code for iSage Rx is NDC.

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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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