510(k) K042572

KENDALL CO2NFIRM NOW CO2 DETECTOR by Kendall — Product Code KNT

K042572 is an FDA 510(k) premarket notification submitted by Kendall for the device "KENDALL CO2NFIRM NOW CO2 DETECTOR". The FDA issued a decision of Substantially Equivalent on November 5, 2004. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Kendall has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2004
Date Received
September 21, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type