FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APNEA RISK EVALUATION SYSTEM (ARES)
K Number: K041662
·
Decision Oct 14, 2004
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
155
Applicant Total
11
Review Days
118
Basic Information
- Device Name
- APNEA RISK EVALUATION SYSTEM (ARES)
- K Number
- K041662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ADVANCED BRAIN MONITORING, INC.
- Date Received
- June 18, 2004
- Decision Date
- October 14, 2004
- 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.
Onera STS 2 (ONERA STS 2)
FDA 510(k)
FDA Class 2
·Anesthesiology
Happy Health Home Sleep Test
FDA 510(k)
FDA Class 2
·Anesthesiology
AcuPebble Ox (200)
FDA 510(k)
FDA Class 2
·Anesthesiology
TipTraQ (TTQ001)
FDA 510(k)
FDA Class 2
·Anesthesiology
SANSA HSAT
FDA 510(k)
FDA Class 2
·Anesthesiology
DormoTech NLab
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by ADVANCED BRAIN MONITORING, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K153412 | Sleep Profiler | Mar 14, 2016 | Substantially Equivalent |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | Oct 30, 2015 | Substantially Equivalent |
| K140190 | NIGHT SHIFT | May 29, 2014 | Substantially Equivalent |
| K130007 | SLEEP PROFILER | Apr 17, 2013 | Substantially Equivalent |
| K120450 | SLEEP PROFILER | Sep 19, 2012 | Substantially Equivalent |
| K120447 | X4 | Jun 20, 2012 | Substantially Equivalent |
| K112514 | APNEA RISK EVALUATION SYSTEM (ARES) | Jan 9, 2012 | Substantially Equivalent |
| K111110 | APNEA GUARD | Jul 22, 2011 | Substantially Equivalent |
| K111194 | APNEA RISK EVALUATION SYSTEM (ARES) | Jul 7, 2011 | Substantially Equivalent |
| K071230 | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 | Oct 3, 2007 | Substantially Equivalent |