510(k) K243426
K243426 is an FDA 510(k) premarket notification submitted by Headsafe Mfg Pty, Ltd. for the device "Nurochek-Pro System". The FDA issued a decision of Substantially Equivalent on March 27, 2025. The device falls under product code PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid), a Class II device regulated under 21 CFR 882.1450. Headsafe Mfg Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2025
- Date Received
- November 4, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1450
- Review Panel
- NE
- Submission Type
A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.