510(k) K833723

MODEL 2000 AMBULATORY MED. INFUSER by Parker Hannifin Corp. — Product Code FRN

K833723 is an FDA 510(k) premarket notification submitted by Parker Hannifin Corp. for the device "MODEL 2000 AMBULATORY MED. INFUSER". The FDA issued a decision of Substantially Equivalent on January 30, 1984. 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
January 30, 1984
Date Received
October 24, 1983
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