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 |