Healthdyne, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Healthdyne, Inc. - FDA 510(k) Cleared Devices
35
Total
35
Cleared
0
Denied
Healthdyne, Inc. has 35 FDA 510(k) cleared anesthesiology devices. Based in Mchenry, US.
Historical record: 35 cleared submissions from 1978 to 1995.
Browse the complete list of FDA 510(k) cleared anesthesiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Healthdyne, Inc.
35 devices
Cleared
Sep 21, 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
Anesthesiology
237d
Cleared
Jul 06, 1994
ALICE
Neurology
792d
Cleared
May 27, 1994
H-500 ALLIANCE OXYGEN CONCENTRATOR
Anesthesiology
10d
Cleared
Apr 04, 1994
FLOW SPIROMETER
Anesthesiology
202d
Cleared
Jan 07, 1993
OH-500 OXYGEN CONCENTRATOR
Anesthesiology
142d
Cleared
Dec 01, 1992
NEBULIZER SYSTEM
Anesthesiology
182d
Cleared
Feb 14, 1991
DATA RECORDER
General Hospital
34d
Cleared
Aug 17, 1990
MODEL 900S APNEA/HEART MONITOR
Anesthesiology
37d
Cleared
Jan 22, 1990
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
Obstetrics & Gynecology
230d
Cleared
May 23, 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
Cardiovascular
56d
Cleared
Jan 31, 1989
H-3000 OXYGEN CONCENTRATOR
Anesthesiology
18d
Cleared
Jun 24, 1988
NASAL CPAP SYSTEM
Anesthesiology
56d