The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Co2/o2 Nasal Cannula (with 4 (10cm) O2 And Co2 Tube), Co2/o2 Nasal Cannula (with 8 (240cm) O2 And 4 (10cm) Co2 Tube),.
| Device ID | K131410 |
| 510k Number | K131410 |
| Device Name: | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SOUTHMEDIC, INC. 50 ALLIANCE BLVD., Barrie, Ontario, CA L4m 5k3 |
| Contact | Tish Anger |
| Correspondent | Tish Anger SOUTHMEDIC, INC. 50 ALLIANCE BLVD., Barrie, Ontario, CA L4m 5k3 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2014-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10620974001642 | K131410 | 000 |
| 10620974001147 | K131410 | 000 |
| 10620974001277 | K131410 | 000 |
| 10620974001307 | K131410 | 000 |
| 10620974001314 | K131410 | 000 |
| 10620974001376 | K131410 | 000 |
| 10620974001444 | K131410 | 000 |
| 10620974001260 | K131410 | 000 |
| 10620974001420 | K131410 | 000 |
| 10620974001437 | K131410 | 000 |
| 10620974001451 | K131410 | 000 |
| 10620974001468 | K131410 | 000 |
| 10620974001130 | K131410 | 000 |