Polysmith Sleep System, Model NTI7593
FDA 510(k) K161650 · Neurotronics, Inc.
510(k) numberK161650
Submission
- Device name
- Polysmith Sleep System, Model NTI7593
- Applicant
- Neurotronics, Inc.
Gainesville, FL, US - Received
- June 15, 2016
- Decision date
- January 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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.
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More from Neurotronics, Inc.
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| K181709 | Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional | 11/16/2018SE |
| K173868 | Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional | 07/02/2018SE |
| K142774 | Polysmith Sleep SystemOLV · Traditional | 02/18/2015SE |
| K131415 | Live View Panel (LVP)OLV · Traditional | 08/09/2013SE |
| K092699 | Nomad Sleep System Recorder, Model PMU800GWL · Traditional | 03/18/2010SE |
| K062943 | Polysmith Sleep System, Model NTI5498OLZ · Traditional | 05/09/2007SE |
| K971803 | Neurotronics Polysomnography System 101MNR · Traditional | 11/12/1997SE |
Questions and answers
When was Polysmith Sleep System, Model NTI7593 cleared by the FDA?
Polysmith Sleep System, Model NTI7593 (K161650) received a 510(k) decision of Substantially Equivalent on January 19, 2017, 218 days after the submission was received.
What is the product code of K161650?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.