510(k) K811918

AMP MARK IV INFUSION PUMP by American Medical Products, Inc. — Product Code FRN

K811918 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "AMP MARK IV INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. American Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
July 2, 1981
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