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BrainTemp Neonate System (BTNeo System)

DEN200042 Class II Direct
Decision Date
2022-03-29
Sponsor / Applicant
Brain Temp, Inc.

Technical Specification

510(k) Submission ID DEN200042
Product Code QSL
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1565
Decision Date 2022-03-29
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

BrainTemp Neonate System (BTNeo System) received FDA 510(k) clearance under submission number DEN200042, sponsored by Brain Temp, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-03-29.

Classification & Regulation

This clearance is catalogued under FDA product code QSL and 21 CFR 882.1565, within the Neurology review panel as a Class II device.