Medical Device Manufacturer · US , Walker , MI

Aequitron Medical, Inc. - FDA 510(k) Cleared Devices

24 submissions · 22 cleared · Since 1984

24

Total

22

Cleared

0

Denied

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

15 devices

1-12 of 15

Cleared Apr 18, 1997

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

Anesthesiology · 333d

Cleared Jun 20, 1996

MODEL LP-1000 VOLUME VENTILATOR

Anesthesiology · 364d

Cleared Nov 08, 1994

OXYGEN CONCENTRATION INDICATOR

Anesthesiology · 48d

Cleared Sep 10, 1992

MODEL 6213 REMOTE ALARM

Anesthesiology · 343d

Cleared Mar 11, 1992

PORTABLE OXYGEN GENERATOR

Anesthesiology · 103d

Cleared Apr 10, 1991

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550

Anesthesiology · 273d

Cleared Nov 30, 1990

CONTINUOUS VOLUME VENTILATOR MODEL LP10

Anesthesiology · 142d

Cleared Nov 30, 1990

MODEL LP6 VENTILATOR, MODIFICATION

Anesthesiology · 10d

Cleared Jul 13, 1990

MODEL 9200 RESPIRATION/HEART RATE MONITOR

Anesthesiology · 94d

Cleared Jul 13, 1990

MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON

Anesthesiology · 17d

Cleared Jan 30, 1989

MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR

Anesthesiology · 84d

Cleared Jun 10, 1988

MODEL 9216 RESPIRATION/HEART RATE MONITOR

Anesthesiology · 78d