510(k) K844556

KHM 2000 DRIP WATCHER by The Timeter Group — Product Code FLN

K844556 is an FDA 510(k) premarket notification submitted by The Timeter Group for the device "KHM 2000 DRIP WATCHER". The FDA issued a decision of Substantially Equivalent on January 14, 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. The Timeter Group has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1985
Date Received
November 21, 1984
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