510(k) K760931

I.V. DRIP MONITOR ALARM DEVICE, MONIFLO by Diemolding Corp. — Product Code FLN

K760931 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "I.V. DRIP MONITOR ALARM DEVICE, MONIFLO". The FDA issued a decision of Substantially Equivalent on January 5, 1977. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1977
Date Received
October 29, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type