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FDA 510(k)

CT3000Pro

K-Number: K212830 · 2021-12-21

ApplicantSrs Medical
Decision Date2021-12-21
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CT3000Pro is a medical device manufactured by Srs Medical. It received FDA 510(k) clearance on 2021-12-21 under approval number K212830. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT3000Pro?

CT3000Pro is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Srs Medical. The 510(k) number is K212830.

When was CT3000Pro approved by the FDA?

CT3000Pro received FDA 510(k) clearance on 2021-12-21, under approval number K212830.

What company makes CT3000Pro?

CT3000Pro is manufactured by Srs Medical.

What is the FDA product code for CT3000Pro?

The FDA product code for CT3000Pro is FEN.

Other Devices by Srs Medical

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.