KENDALL CO2NFIRM NOW CO2 DETECTOR— 510(k) K042572
Substantially EquivalentKendall
FDA 510(k) clearance K042572 for KENDALL CO2NFIRM NOW CO2 DETECTOR, Substantially Equivalent on 2004-11-05. Applicant: Kendall. Device class: 2.
Clearance details
- Applicant
- Kendall
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code KNT
view allMore clearances from Kendall
view all- K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT
- K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
- K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
- K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
- K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.