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FDA 510(k)

Bullsai Confirm

K-Number: K243520 · 2025-03-28

Decision Date2025-03-28
Product CodeQQC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Bullsai Confirm is a medical device manufactured by Turing Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-28 under approval number K243520. The device is classified under product code QQC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bullsai Confirm?

Bullsai Confirm is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Turing Medical Technologies, Inc.. The 510(k) number is K243520.

When was Bullsai Confirm approved by the FDA?

Bullsai Confirm received FDA 510(k) clearance on 2025-03-28, under approval number K243520.

What company makes Bullsai Confirm?

Bullsai Confirm is manufactured by Turing Medical Technologies, Inc..

What is the FDA product code for Bullsai Confirm?

The FDA product code for Bullsai Confirm is QQC.

Other Devices by Turing Medical Technologies, Inc.

Related Devices (Code: QQC)

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.