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FDA 510(k)

CT-STOR

K-Number: K201789 · 2021-09-20

ApplicantEnergy Delivery Solutions
Decision Date2021-09-20
Product CodeNDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CT-STOR is a medical device manufactured by Energy Delivery Solutions. It received FDA 510(k) clearance on 2021-09-20 under approval number K201789. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT-STOR?

CT-STOR is a medical device that received FDA 510(k) clearance on 2021-09-20. It is manufactured by Energy Delivery Solutions. The 510(k) number is K201789.

When was CT-STOR approved by the FDA?

CT-STOR received FDA 510(k) clearance on 2021-09-20, under approval number K201789.

What company makes CT-STOR?

CT-STOR is manufactured by Energy Delivery Solutions.

What is the FDA product code for CT-STOR?

The FDA product code for CT-STOR is NDS.

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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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