The following data is part of a premarket notification filed by Flexicare with the FDA for Co2 Monitoring Line, Co2 Monitoring Line With Filter.
| Device ID | K133516 |
| 510k Number | K133516 |
| Device Name: | CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | FLEXICARE CYNON VALLEY BUSINESS PARK MOUNTAIN ASH Mid Glam, GB Cf454er |
| Contact | Christopher Watkins |
| Correspondent | Christopher Watkins FLEXICARE CYNON VALLEY BUSINESS PARK MOUNTAIN ASH Mid Glam, GB Cf454er |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055931127727 | K133516 | 000 |
| 05055931127840 | K133516 | 000 |
| 05055931127857 | K133516 | 000 |
| 05055788716402 | K133516 | 000 |
| 05055788716419 | K133516 | 000 |
| 05055788716440 | K133516 | 000 |
| 05055788716457 | K133516 | 000 |
| 05055788716778 | K133516 | 000 |
| 05055788754749 | K133516 | 000 |
| 05055931127833 | K133516 | 000 |
| 05055931127826 | K133516 | 000 |
| 05055931127819 | K133516 | 000 |
| 05055931127734 | K133516 | 000 |
| 05055931127741 | K133516 | 000 |
| 05055931127758 | K133516 | 000 |
| 05055931127765 | K133516 | 000 |
| 05055931127772 | K133516 | 000 |
| 05055931127789 | K133516 | 000 |
| 05055931127796 | K133516 | 000 |
| 05055931127802 | K133516 | 000 |
| 05055788754770 | K133516 | 000 |
| 05055788754800 | K133516 | 000 |
| 05055788754831 | K133516 | 000 |
| 05055788762157 | K133516 | 000 |
| 05055788762201 | K133516 | 000 |
| 05055788781691 | K133516 | 000 |
| 05055788781714 | K133516 | 000 |
| 05055788781875 | K133516 | 000 |
| 05055788781899 | K133516 | 000 |
| 05055788781912 | K133516 | 000 |
| 05055788782001 | K133516 | 000 |
| 05055788762096 | K133516 | 000 |
| 05055788762034 | K133516 | 000 |
| 05055788761952 | K133516 | 000 |
| 05055788755272 | K133516 | 000 |
| 05055788755302 | K133516 | 000 |
| 05055788755333 | K133516 | 000 |
| 05055788755364 | K133516 | 000 |
| 05055788761884 | K133516 | 000 |
| 05055788761907 | K133516 | 000 |
| 05055788761921 | K133516 | 000 |
| 05055788761945 | K133516 | 000 |
| 05055788782032 | K133516 | 000 |