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 Medix Medical Electronics (U.S.A.), Inc..

39
Total
39
Cleared
93d
Avg days
1976
Since
39 devices
25–39 of 39
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 Sep 16, 1980
I.V. SENTRY ALARM DEVICE
K802101
Pike Medical Co.
General Hospital · 13d
Cleared Jul 30, 1979
GUARDIAN II I.V. CONTROLLER
K790836
Centaur Sciences, Inc.
General Hospital · 91d
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 Oct 27, 1978
MONITOR, GRAVITY IRRIGATION DRIP
K781717
Syntel, Inc.
General Hospital · 16d
Cleared Oct 25, 1978
INTRA-ALERT
K781297
Pan-Tech Research, Inc.
General Hospital · 90d
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
Cleared Jan 05, 1977
I.V. DRIP MONITOR ALARM DEVICE, MONIFLO
K760931
Diemolding Corp.
General Hospital · 68d
Cleared Dec 23, 1976
ARNCO I.V. MONITOR
K760694
A.R. Nelson Co., Inc.
General Hospital · 92d