K223922 is an FDA 510(k) clearance for the SOMNUM (V.1.1.2.). This device is classified as a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II - Special Controls, product code OLZ).
Submitted by Honeynaps Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on August 16, 2023, 229 days after receiving the submission on December 30, 2022.
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 | K223922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2022 |
| Decision Date | August 16, 2023 |
| Days to Decision | 229 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 |