FLN · Class II · 21 CFR 880.2420

FDA Product Code FLN: Monitor, Electric For Gravity Flow Infusion Systems

Leading manufacturers include Imed Corp., Travenol Laboratories, S.A. and Pollak (Intl.), Ltd..

39
Total
39
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Monitor, Electric For Gravity Flow Infusion Systems Devices (Product Code FLN)

39 devices
1–24 of 39
Cleared May 25, 2018
DripAssist Plus
K172242
Shift Labs, Inc.
General Hospital · 303d
Cleared Oct 13, 2015
DripAssist
K150687
Shift Labs
General Hospital · 210d
Cleared Apr 24, 2014
FLUID LEVEL MONITOR
K133870
Coleman Laboratories
General Hospital · 125d
Cleared Feb 22, 2006
ISSYS DRUG FLOW MONITOR
K050783
Integrated Sensing Systems, Inc.
General Hospital · 331d
Cleared Feb 14, 2006
LEVELERT II FLUID LEVEL SENSOR
K060123
Smith & Nephew, Inc.
General Hospital · 27d
Cleared Aug 06, 2002
STRYKER L3 HYDROLERT
K022248
Stryker Endoscopy
General Hospital · 25d
Cleared Nov 20, 1997
FLUID CENTURION (4-100-00)
K973025
Northgate Technologies, Inc.
General Hospital · 98d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084
Alexander Mfg. Co.
General Hospital · 29d
Cleared Aug 30, 1990
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193
Smith & Nephew Dyonics, Inc.
General Hospital · 42d
Cleared Apr 04, 1985
TRAVENOL FLO-GARD 500 IV MONITOR
K850710
Travenol Laboratories, S.A.
General Hospital · 41d
Cleared Jul 12, 1983
DROP RATE COUNTER #340
K831596
Imed Corp.
General Hospital · 56d
Cleared Jan 26, 1983
MODEL 460 INTERMITTENT MEDICATION DELIV
K823018
Y
General Hospital · 105d
Cleared Aug 16, 1982
I.V. SENTINEL
K821823
The John Bunn Co.
General Hospital · 55d
Cleared Nov 12, 1980
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
K802166
Baxter Healthcare Corp
General Hospital · 65d
Cleared Oct 31, 1980
INFUSSION ALARM SYSTEM I.A.S. CAT.#1118
K802011
Pollak (Intl.), Ltd.
General Hospital · 72d
Cleared Oct 23, 1980
IMED DROP RATE CALCULATOR #340
K801734
Imed Corp.
General Hospital · 90d
Cleared May 14, 1979
DROP CONTROLLER
K790669
Imed Corp.
General Hospital · 38d
Cleared Nov 22, 1978
VOLUMETRIC CONTROLLER MODEL 310
K781589
Imed Corp.
General Hospital · 65d
Cleared Apr 10, 1978
PARENTERAL INFUSION CONTROLLER
K780223
Travenol Laboratories, S.A.
General Hospital · 60d
Cleared Feb 21, 1978
PARENTERAL INFUSION CONTROLLER, ELEC.
K780106
National Patent Development Corp.
General Hospital · 32d

About Product Code FLN - Regulatory Context