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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 the device name listed in this FDA 510(k) record. The listed applicant is Deltronix Equipamentos Ltda. It received FDA 510(k) clearance on 2023-04-18 under 510(k) 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. The listed applicant is Deltronix Equipamentos Ltda. The 510(k) number is K223784.

When did Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 receive FDA 510(k) clearance?

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

Who is the listed applicant for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

The FDA 510(k) record lists Deltronix Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.

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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