510(k) K897096

MODEL 404A I.V. INFUSION PUMP ANALYZER by Dynatech/Nevada, Inc. — Product Code FRN

K897096 is an FDA 510(k) premarket notification submitted by Dynatech/Nevada, Inc. for the device "MODEL 404A I.V. INFUSION PUMP ANALYZER". The FDA issued a decision of Substantially Equivalent on March 15, 1990. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Dynatech/Nevada, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1990
Date Received
December 21, 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