K210034 is an FDA 510(k) clearance for the EnsoSleep. This device is classified as a Automatic Event Detection Software For Polysomnograph With Electroencephalograph (Class II - Special Controls, product code OLZ).
Submitted by Ensodata, Inc. (Madison, US). The FDA issued a Cleared decision on June 16, 2021, 161 days after receiving the submission on January 6, 2021.
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 | K210034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2021 |
| Decision Date | June 16, 2021 |
| Days to Decision | 161 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 |