510(k) K870656

IMED(R) 980C VOLUMETRIC INFUSION PUMP by Imed Corp. — Product Code FRN

K870656 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED(R) 980C VOLUMETRIC INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Imed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1987
Date Received
February 18, 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