Medical Device Manufacturer · US , Marietta , GA

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

9 submissions · 9 cleared · Since 1994

9

Total

9

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Mar 19, 1999

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500

Anesthesiology · 157d

Cleared Aug 04, 1998

NASAL INTERFACE MODEL 7910

Anesthesiology · 252d

Cleared Jun 29, 1998

MODEL 7410 VOYAGER

Anesthesiology · 181d

Cleared Jan 20, 1998

TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI...

Anesthesiology · 190d

Cleared Jul 25, 1997

PROTEGE LIQUID OXYGEN SYSTEM

Anesthesiology · 88d

Cleared Apr 16, 1997

MODEL 1700 TRANQUILITY BILEVEL SYSTEM

Anesthesiology · 90d

Cleared Feb 20, 1997

MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV

Anesthesiology · 238d

Cleared Aug 05, 1994

7300 NASAL CPAP SYSTEM

Anesthesiology · 16d