K093728 is an FDA 510(k) clearance for the BE MICRO, TREA. This device is classified as a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV).
Submitted by Eb Neuro S.P.A. (Carmel, US). The FDA issued a Cleared decision on April 29, 2010, 147 days after receiving the submission on December 3, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data..
| 510(k) Number | K093728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2009 |
| Decision Date | April 29, 2010 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLV — Standard Polysomnograph With Electroencephalograph |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data. |