510(k) K811917

I.V. ADMIN. SETS FOR THE AMP MARK IV PMP by American Medical Products, Inc. — Product Code FRN

K811917 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "I.V. ADMIN. SETS FOR THE AMP MARK IV PMP". The FDA issued a decision of Substantially Equivalent on July 23, 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 23, 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