510(k) K875174

RATEMINDER V INFUSION PUMP by Critikon Company, LLC — Product Code FRN

K875174 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "RATEMINDER V INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on March 29, 1988. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Critikon Company, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1988
Date Received
December 17, 1987
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