FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Polysmith Sleep System, Model NTI7593
K Number: K161650
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
9
Review Days
218
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Basic Information
- Device Name
- Polysmith Sleep System, Model NTI7593
- K Number
- K161650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurotronics, Inc.
- Date Received
- June 15, 2016
- Decision Date
- January 19, 2017
- Product Code
- OLV
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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|---|---|---|---|
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| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Jul 2, 2018 | Substantially Equivalent |
| K142774 | Polysmith Sleep System | Feb 18, 2015 | Substantially Equivalent |
| K131415 | LIVE VIEW PANEL (LVP) | Aug 9, 2013 | Substantially Equivalent |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | Mar 18, 2010 | Substantially Equivalent |
| K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | May 9, 2007 | Substantially Equivalent |
| K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 | Nov 12, 1997 | Substantially Equivalent |