K161650 is an FDA 510(k) clearance for the Polysmith Sleep System, Model NTI7593. This device is classified as a Standard Polysomnograph With Electroencephalograph (Class II - Special Controls, product code OLV).
Submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on January 19, 2017, 218 days after receiving the submission on June 15, 2016.
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 | K161650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2016 |
| Decision Date | January 19, 2017 |
| Days to Decision | 218 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. |