FDA 510(k)

Bullsai Confirm

K-Number: K243520 · 2025-03-28

ApplicantTuring Medical Technologies, Inc.

Decision Date2025-03-28

Product CodeQQC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Bullsai Confirm is the device name listed in this FDA 510(k) record. The listed applicant is Turing Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-28 under 510(k) 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. The listed applicant is Turing Medical Technologies, Inc.. The 510(k) number is K243520.

When did Bullsai Confirm receive FDA 510(k) clearance?

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

Who is the listed applicant for Bullsai Confirm?

The FDA 510(k) record lists Turing Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bullsai Confirm?

The FDA product code for Bullsai Confirm is QQC.

Other records listing Turing Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241094Bullsai

Related Devices (Code: QQC)

K213930Brainlab Elements Guide XT, Guide 3.0Brainlab AG

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.