510(k) K853549

MCGAW/DROP WATCH FLOW MONITOR by American Mcgaw — Product Code FLN

K853549 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "MCGAW/DROP WATCH FLOW MONITOR". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. American Mcgaw has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
August 26, 1985
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