K231914 is an FDA 510(k) clearance for the Nurochek-II System. This device is classified as a Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid (Class II - Special Controls, product code PIW).
Submitted by Headsafe Mfg Pty, Ltd. (Surry Hills, AU). The FDA issued a Cleared decision on December 27, 2023, 181 days after receiving the submission on June 29, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1450. 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..
| 510(k) Number | K231914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2023 |
| Decision Date | December 27, 2023 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PIW - Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1450 |
| Definition | 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. |