510(k) K870524

AMBULATORY INFUSION PUMP DRUG RESERVOIR by Med Fusion Systems, Inc. — Product Code FRN

K870524 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "AMBULATORY INFUSION PUMP DRUG RESERVOIR". The FDA issued a decision of Substantially Equivalent on May 6, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
February 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type