FDA 510(k)

Bullsai

K-Number: K241094 · 2024-08-13

ApplicantTuring Medical Technologies, Inc.

Decision Date2024-08-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bullsai 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 2024-08-13 under 510(k) number K241094. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bullsai?

Bullsai is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Turing Medical Technologies, Inc.. The 510(k) number is K241094.

When did Bullsai receive FDA 510(k) clearance?

Bullsai received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241094.

Who is the listed applicant for Bullsai?

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?

The FDA product code for Bullsai is LLZ.

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.

K243520Bullsai Confirm

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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.