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FDA 510(k)

Ultraphon Chemical Indicator (TRO-T and TRO-B)

K-Number: K233413 · 2024-06-26

ApplicantTrue Indicating, LLC
Decision Date2024-06-26
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ultraphon Chemical Indicator (TRO-T and TRO-B) is a medical device manufactured by True Indicating, LLC. It received FDA 510(k) clearance on 2024-06-26 under approval number K233413. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultraphon Chemical Indicator (TRO-T and TRO-B)?

Ultraphon Chemical Indicator (TRO-T and TRO-B) is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by True Indicating, LLC. The 510(k) number is K233413.

When was Ultraphon Chemical Indicator (TRO-T and TRO-B) approved by the FDA?

Ultraphon Chemical Indicator (TRO-T and TRO-B) received FDA 510(k) clearance on 2024-06-26, under approval number K233413.

What company makes Ultraphon Chemical Indicator (TRO-T and TRO-B)?

Ultraphon Chemical Indicator (TRO-T and TRO-B) is manufactured by True Indicating, LLC.

What is the FDA product code for Ultraphon Chemical Indicator (TRO-T and TRO-B)?

The FDA product code for Ultraphon Chemical Indicator (TRO-T and TRO-B) is JOJ.

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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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