510(k) K880538

TRACK AND CARRIER, INTRAVENOUS by Ferguson Medical — Product Code FOX

K880538 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "TRACK AND CARRIER, INTRAVENOUS". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Ferguson Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1988
Date Received
February 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
Submission Type