Medical Device Manufacturer · US , Mchenry , IL

Healthdyne, Inc. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 1978

35

Total

35

Cleared

0

Denied

FDA 510(k) Regulatory Record - Healthdyne, Inc. Anesthesiology ✕

27 devices

1-12 of 27

Cleared Sep 21, 1995

PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)

Anesthesiology · 237d

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 Aug 17, 1990

MODEL 900S APNEA/HEART MONITOR

Anesthesiology · 37d

Cleared Jan 31, 1989

H-3000 OXYGEN CONCENTRATOR

Anesthesiology · 18d

Cleared Jun 24, 1988

NASAL CPAP SYSTEM

Anesthesiology · 56d

Cleared Feb 12, 1988

OXYGEN/PULSE MONITOR

Anesthesiology · 67d

Cleared Feb 11, 1988

HEALTHDYNE RATE METER

Anesthesiology · 79d

Cleared May 21, 1986

Anesthesiology · 29d

Cleared Jan 30, 1986

HEALTHDYNE'S EVENT RECORDER SYSTEM

Anesthesiology · 6d