Aequitron Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K961972MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITORApril 18, 1997
K952880MODEL LP-1000 VOLUME VENTILATORJune 20, 1996
K944654OXYGEN CONCENTRATION INDICATORNovember 8, 1994
K914424MODEL 6213 REMOTE ALARMSeptember 10, 1992
K915381PORTABLE OXYGEN GENERATORMarch 11, 1992
K911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)September 19, 1991
K903020RESPIRATION/HEART RATE MONITOR MODEL 9500/9550April 10, 1991
K903010CONTINUOUS VOLUME VENTILATOR MODEL LP10November 30, 1990
K905244MODEL LP6 VENTILATOR, MODIFICATIONNovember 30, 1990
K902785MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MONJuly 13, 1990
K901656MODEL 9200 RESPIRATION/HEART RATE MONITORJuly 13, 1990
K901251MODEL 9101 RECORDER/ANALYZER SYSTEMMay 22, 1990
K882080MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.March 1, 1989
K884637MODEL 9550/9500 RESPIRATION/HEART RATE MONITORJanuary 30, 1989
K881266MODEL 9216 RESPIRATION/HEART RATE MONITORJune 10, 1988
K872954MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOROctober 9, 1987
K871551MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITORJune 5, 1987
K853856EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMETMarch 12, 1986
K853084MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)August 2, 1985
K850181AEQUITRON MED-7100 PHOTOTHERAPY LIGHTApril 5, 1985