510(k) K897086

PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 by Parker Hannifin Corp. — Product Code FRN

K897086 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "PARKER AMBULATORY MEDICATION INFUSION PUMP 2004". The FDA issued a decision of Substantially Equivalent on September 28, 1990. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Parker Hannifin Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1990
Date Received
December 20, 1989
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