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FDA 510(k)

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200

K-Number: K223784 · 2023-04-18

ApplicantDeltronix Equipamentos Ltda
Decision Date2023-04-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 is a medical device manufactured by Deltronix Equipamentos Ltda. It received FDA 510(k) clearance on 2023-04-18 under approval number K223784. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 is a medical device that received FDA 510(k) clearance on 2023-04-18. It is manufactured by Deltronix Equipamentos Ltda. The 510(k) number is K223784.

When was Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 approved by the FDA?

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 received FDA 510(k) clearance on 2023-04-18, under approval number K223784.

What company makes Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 is manufactured by Deltronix Equipamentos Ltda.

What is the FDA product code for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

The FDA product code for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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