FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APNEA GUARD
K Number: K111110
·
Decision Jul 22, 2011
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
194
Applicant Total
11
Review Days
93
Basic Information
- Device Name
- APNEA GUARD
- K Number
- K111110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ADVANCED BRAIN MONITORING, INC.
- Date Received
- April 20, 2011
- Decision Date
- July 22, 2011
- Product Code
- LRK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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Other Clearances by ADVANCED BRAIN MONITORING, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K111194 | APNEA RISK EVALUATION SYSTEM (ARES) | Jul 7, 2011 | Substantially Equivalent |
| K071230 | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 | Oct 3, 2007 | Substantially Equivalent |
| K041662 | APNEA RISK EVALUATION SYSTEM (ARES) | Oct 14, 2004 | Substantially Equivalent |