The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for Apnea Guard.
| Device ID | K111110 |
| 510k Number | K111110 |
| Device Name: | APNEA GUARD |
| Classification | Device, Anti-snoring |
| Applicant | ADVANCED BRAIN MONITORING, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ADVANCED BRAIN MONITORING, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-20 |
| Decision Date | 2011-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851113007147 | K111110 | 000 |
| 30850015266004 | K111110 | 000 |
| 20850015266021 | K111110 | 000 |
| 20850015266014 | K111110 | 000 |
| 20850015266007 | K111110 | 000 |
| 00850015266393 | K111110 | 000 |
| 00850015266386 | K111110 | 000 |
| 00850015266379 | K111110 | 000 |
| 00850015266362 | K111110 | 000 |
| 00850015266485 | K111110 | 000 |
| 00850015266478 | K111110 | 000 |
| 00850015266461 | K111110 | 000 |
| 00850015266454 | K111110 | 000 |
| 00850015266447 | K111110 | 000 |
| 00850015266430 | K111110 | 000 |
| 30850015266011 | K111110 | 000 |
| 30850015266028 | K111110 | 000 |
| 00851113007130 | K111110 | 000 |
| 00851113007086 | K111110 | 000 |
| 00851113007079 | K111110 | 000 |
| 10851113007069 | K111110 | 000 |
| 10851113007052 | K111110 | 000 |
| 00851113007048 | K111110 | 000 |
| 00850015266041 | K111110 | 000 |
| 00850015266034 | K111110 | 000 |
| 00850015266027 | K111110 | 000 |
| 00850015266010 | K111110 | 000 |
| 00850015266003 | K111110 | 000 |
| 00850015266065 | K111110 | 000 |
| 00850015266270 | K111110 | 000 |
| 00850015266263 | K111110 | 000 |
| 00850015266058 | K111110 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() APNEA GUARD 77964268 3924323 Live/Registered |
Advanced Brain Monitoring, Inc. 2010-03-21 |