510(k) K895922

METRICARE EMPTY CONTAINER SYSTEMS by Metrix Co. — Product Code LHI

K895922 is an FDA 510(k) premarket notification submitted by Metrix Co. for the device "METRICARE EMPTY CONTAINER SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Metrix Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
October 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type