FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
K Number: K971803
·
Decision Nov 12, 1997
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
9
Review Days
184
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
- K Number
- K971803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurotronics, Inc.
- Date Received
- May 12, 1997
- Decision Date
- November 12, 1997
- Product Code
- MNR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNR), ordered by most recent decision date.
CASSIE
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
WatchPAT400 (WP400)
FDA 510(k)
FDA Class 2
·Anesthesiology
Somfit D
FDA 510(k)
FDA Class 2
·Anesthesiology
Onera STS 2 (ONERA STS 2)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Neurotronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220631 | NomadAir PMU810 | Jul 15, 2022 | Substantially Equivalent |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Nov 16, 2018 | Substantially Equivalent |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Jul 2, 2018 | Substantially Equivalent |
| K161650 | Polysmith Sleep System, Model NTI7593 | Jan 19, 2017 | 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 |