K071782 is an FDA 510(k) clearance for the MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES. This device is classified as a Standard Polysomnograph With Electroencephalograph (Class II - Special Controls, product code OLV).
Submitted by Micromed S.P.A. (Mogliano Veneto (Tv), IT). The FDA issued a Cleared decision on January 10, 2008, 192 days after receiving the submission on July 2, 2007.
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 | K071782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2007 |
| Decision Date | January 10, 2008 |
| Days to Decision | 192 days |
| Submission Type | Abbreviated |
| 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. |