510(k) K043044

ANTI-I.V. ENTERAL FEEDING SYSTEM by Viasys Medsystems — Product Code KNT

K043044 is an FDA 510(k) premarket notification submitted by Viasys Medsystems for the device "ANTI-I.V. ENTERAL FEEDING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 6, 2005. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Viasys Medsystems has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2005
Date Received
November 4, 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