FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
RemLogic
K Number: K162140
·
Decision Dec 1, 2016
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
35
Applicant Total
8
Review Days
122
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
- RemLogic
- K Number
- K162140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Embla Systems
- Date Received
- August 1, 2016
- Decision Date
- December 1, 2016
- Product Code
- OLZ
- 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 |
|---|---|---|---|
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLZ), ordered by most recent decision date.
Onera SleepMap (SLEEPMAP)
FDA 510(k)
FDA Class 2
·Neurology
Hypnos (369054-200)
FDA 510(k)
FDA Class 2
·Neurology
DeepRESP
FDA 510(k)
FDA Class 2
·Neurology
NEAT 001
FDA 510(k)
FDA Class 2
·Neurology
DeepRESP
FDA 510(k)
FDA Class 2
·Neurology
Dreem 3S
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Embla Systems
| K Number | Device Name | ||
|---|---|---|---|
| K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | Sep 27, 2019 | Substantially Equivalent |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | Mar 1, 2019 | Substantially Equivalent |
| K172703 | Disposable Snap Electrode | Nov 13, 2017 | Substantially Equivalent |
| K163617 | REMbrandt | Apr 11, 2017 | Substantially Equivalent |
| K153353 | SANDMAN ELITE | Jun 23, 2016 | Substantially Equivalent |
| K122516 | EMBLETTA MPR | Feb 21, 2013 | Substantially Equivalent |
| K111742 | MDRIVE | Aug 31, 2011 | Substantially Equivalent |