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FDA 510(k)

LOCATOR R-Tx

K-Number: K200827 · 2020-09-02

ApplicantIvory Super Holdco, Incp.
Decision Date2020-09-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LOCATOR R-Tx is a medical device manufactured by Ivory Super Holdco, Incp.. It received FDA 510(k) clearance on 2020-09-02 under approval number K200827. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOCATOR R-Tx?

LOCATOR R-Tx is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Ivory Super Holdco, Incp.. The 510(k) number is K200827.

When was LOCATOR R-Tx approved by the FDA?

LOCATOR R-Tx received FDA 510(k) clearance on 2020-09-02, under approval number K200827.

What company makes LOCATOR R-Tx?

LOCATOR R-Tx is manufactured by Ivory Super Holdco, Incp..

What is the FDA product code for LOCATOR R-Tx?

The FDA product code for LOCATOR R-Tx is NHA.

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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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