The following data is part of a premarket notification filed by Carefusion with the FDA for End Tidal Co2 Nasal Cannula.
| Device ID | K120518 |
| 510k Number | K120518 |
| Device Name: | END TIDAL CO2 NASAL CANNULA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Contact | Erika Fernandez |
| Correspondent | Erika Fernandez CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60085 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30889483579330 | K120518 | 000 |
| 30889483579286 | K120518 | 000 |
| 30889483579255 | K120518 | 000 |
| 30889483579194 | K120518 | 000 |
| 30889483579187 | K120518 | 000 |
| 30889483579118 | K120518 | 000 |