The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for O2 Nasal Cannula With Co2 Monitoring.
| Device ID | K140113 |
| 510k Number | K140113 |
| Device Name: | O2 NASAL CANNULA WITH CO2 MONITORING |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUTAIN ASH Mid Glamorgan, GB Cf45 4er |
| Contact | Chris Watkins |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-01-15 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788782476 | K140113 | 000 |
| 05055788755432 | K140113 | 000 |
| 05055788754916 | K140113 | 000 |
| 05055788754909 | K140113 | 000 |
| 05055788754862 | K140113 | 000 |
| 05055788754855 | K140113 | 000 |
| 05055788754718 | K140113 | 000 |
| 05055788754688 | K140113 | 000 |
| 05055788716495 | K140113 | 000 |
| 05055788716488 | K140113 | 000 |
| 05055931101079 | K140113 | 000 |
| 05055931101048 | K140113 | 000 |
| 05055788716433 | K140113 | 000 |
| 05055788716426 | K140113 | 000 |
| 05055931101062 | K140113 | 000 |
| 05055931101055 | K140113 | 000 |
| 05055931101031 | K140113 | 000 |
| 05055788755456 | K140113 | 000 |
| 05055788755470 | K140113 | 000 |
| 05055788755487 | K140113 | 000 |
| 05055788782117 | K140113 | 000 |
| 05055788782100 | K140113 | 000 |
| 05055788781981 | K140113 | 000 |
| 05055788781950 | K140113 | 000 |
| 05055788781936 | K140113 | 000 |
| 05055788781851 | K140113 | 000 |
| 05055788781837 | K140113 | 000 |
| 05055788781813 | K140113 | 000 |
| 05055788781790 | K140113 | 000 |
| 05055788781752 | K140113 | 000 |
| 05055788781738 | K140113 | 000 |
| 05055788781639 | K140113 | 000 |
| 05055788755586 | K140113 | 000 |
| 05055788755579 | K140113 | 000 |
| 05055788755531 | K140113 | 000 |
| 05055788755524 | K140113 | 000 |
| 05055931101024 | K140113 | 000 |