Bullsai Confirm— 510(k) K243520

Name: FDA 510(k) clearance K243520
Creator: U.S. Food and Drug Administration
Published: 2025-03-28

Substantially Equivalent

Turing Medical Technologies, Inc.

FDA 510(k) clearance K243520 for Bullsai Confirm, Substantially Equivalent on 2025-03-28. Applicant: Turing Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Turing Medical Technologies, Inc.
Product code: Code QQC
Device class: Class 2
Regulation: 21 CFR 882.5855
Advisory panel: Neurology
Date received: 2024-11-13
Decision date: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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