510(k) K902092

RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY by Critikon Company, LLC — Product Code FRN

K902092 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY". The FDA issued a decision of Substantially Equivalent on July 26, 1990. 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
July 26, 1990
Date Received
May 9, 1990
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