510(k) K161650
K161650 is an FDA 510(k) premarket notification submitted by Neurotronics, Inc. for the device "Polysmith Sleep System, Model NTI7593". The FDA issued a decision of Substantially Equivalent on January 19, 2017. The device falls under product code OLV (Standard Polysomnograph With Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Neurotronics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2017
- Date Received
- June 15, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Standard Polysomnograph With Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
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.