510(k) K854157

PMT ACCUPRESSURE INFUSION SYSTEM 3601 by Progress Mankind Technology — Product Code FRN

K854157 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "PMT ACCUPRESSURE INFUSION SYSTEM 3601". The FDA issued a decision of Substantially Equivalent on February 13, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Progress Mankind Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1986
Date Received
October 11, 1985
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