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

35 devices

26-35 of 35

Cleared Oct 22, 1982

MODEL BX-3000 OXYGEN CONCENTRATOR

Anesthesiology · 25d

Cleared Jul 14, 1982

MODEL 16800 TREND RECORDER

Cardiovascular · 42d

Cleared Jul 13, 1982

HEALTHDYNE MODEL 16900 INFANT MONITOR

Anesthesiology · 42d

Cleared Apr 15, 1982

Anesthesiology · 37d

Cleared Feb 04, 1982

Anesthesiology · 77d

Cleared Feb 12, 1981

MEAN PRESSURE MONITOR

Anesthesiology · 13d

Cleared Dec 18, 1980

INFANT VENTILATOR, (RESPIRATOR) PLAN B

Anesthesiology · 59d

Cleared Oct 03, 1980

ECG/RESPIRATION STIMULATOR

Anesthesiology · 22d

Cleared Dec 21, 1978

VENTILATOR, INFANT MODEL 100

Anesthesiology · 43d

Cleared Nov 14, 1978

TEMPERATURE CONTROLLER MODEL 17000

Anesthesiology · 69d