The following data is part of a premarket notification filed by Apnea Sciences Corporation with the FDA for Snorerx.
Device ID | K153200 |
510k Number | K153200 |
Device Name: | SnoreRx |
Classification | Device, Anti-snoring |
Applicant | Apnea Sciences Corporation 27121 Aliso Creek Road, Bldg 140 Aliso Viejo, CA 92656 |
Contact | James Fallon |
Correspondent | James Smith Apnea Sciences Corporation 29442 Pointe Royale Laguna Niguel, CA 92677 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-04 |
Decision Date | 2016-08-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861481000350 | K153200 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SNORERX 86362229 4688791 Live/Registered |
Fallon, James S. 2014-08-10 |
![]() SNORERX 85479904 not registered Dead/Abandoned |
Lynne A. Sammons 2011-11-23 |
![]() SNORERX 85216355 4113891 Dead/Cancelled |
Fallon, James S. 2011-01-12 |