510(k) K030888

EVA EMPTY SOLUTION CONTAINER by Metrix Co. — Product Code KPE

K030888 is an FDA 510(k) premarket notification submitted by Metrix Co. for the device "EVA EMPTY SOLUTION CONTAINER". The FDA issued a decision of Substantially Equivalent on April 2, 2003. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Metrix Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2003
Date Received
March 21, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type