K233438 is an FDA 510(k) clearance for the SleepStageML. This device is classified as a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II - Special Controls, product code OLZ).
Submitted by Beacon Biosignals, Inc. (Boston, US). The FDA issued a Cleared decision on March 8, 2024, 147 days after receiving the submission on October 13, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User.
| 510(k) Number | K233438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2023 |
| Decision Date | March 08, 2024 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLZ - Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User |