Medical Device Manufacturer · US , Mchenry , IL

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

35 submissions · 35 cleared · Since 1978

Total

Cleared

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

1-12 of 35

Cleared Sep 21, 1995

PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)

K950331 · BZD

Anesthesiology · 237d

H-500 ALLIANCE OXYGEN CONCENTRATOR

Anesthesiology · 202d

Cleared Jan 07, 1993

OH-500 OXYGEN CONCENTRATOR

K924146 · CAW

Anesthesiology · 142d

Cleared Dec 01, 1992

NEBULIZER SYSTEM

K922623 · BTI

Anesthesiology · 182d

Cleared Feb 14, 1991

DATA RECORDER

K910118 · FLL

General Hospital · 34d

Cleared Aug 17, 1990

MODEL 900S APNEA/HEART MONITOR

K903287 · BZQ

Anesthesiology · 37d

Cleared Jan 22, 1990

MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR

K894030 · HFM

Obstetrics & Gynecology · 230d

Cleared May 23, 1989

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S

K892006 · DRT

Cardiovascular · 56d

Cleared Jan 31, 1989

H-3000 OXYGEN CONCENTRATOR

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

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