The following data is part of a premarket notification filed by Kendall with the FDA for Kendall Co2nfirm Now Co2 Detector.
| Device ID | K042572 |
| 510k Number | K042572 |
| Device Name: | KENDALL CO2NFIRM NOW CO2 DETECTOR |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Bridget Gardner |
| Correspondent | Bridget Gardner KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2004-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521000275 | K042572 | 000 |