CAPNOMASK
Analyzer, Gas, Carbon-dioxide, Gaseous-phase
MEDIPLUS LTD.
The following data is part of a premarket notification filed by Mediplus Ltd. with the FDA for Capnomask.
Pre-market Notification Details
| Device ID | K131339 |
| 510k Number | K131339 |
| Device Name: | CAPNOMASK |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MEDIPLUS LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MEDIPLUS LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-09 |
| Decision Date | 2013-11-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055140703948 | K131339 | 000 |
| 15055140704013 | K131339 | 000 |
| 15055140704020 | K131339 | 000 |
| 15055140704037 | K131339 | 000 |
| 15055140704044 | K131339 | 000 |
| 15055140704051 | K131339 | 000 |
| 15055140700190 | K131339 | 000 |
| 05055140700834 | K131339 | 000 |
| 15055140700879 | K131339 | 000 |
| 15055140701722 | K131339 | 000 |
| 15055140703849 | K131339 | 000 |
| 15055140703856 | K131339 | 000 |
| 15055140703887 | K131339 | 000 |
| 15055140703894 | K131339 | 000 |
| 15055140703917 | K131339 | 000 |
| 15055140703924 | K131339 | 000 |
| 15055140703931 | K131339 | 000 |
| 15055140704006 | K131339 | 000 |
Trademark Results [CAPNOMASK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPNOMASK 85759947 4718248 Live/Registered |
Mediplus Limited 2012-10-22 |
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