Healthdyne, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)September 21, 1995
K922106ALICEJuly 6, 1994
K942357H-500 ALLIANCE OXYGEN CONCENTRATORMay 27, 1994
K934502FLOW SPIROMETERApril 4, 1994
K924146OH-500 OXYGEN CONCENTRATORJanuary 7, 1993
K922623NEBULIZER SYSTEMDecember 1, 1992
K910118DATA RECORDERFebruary 14, 1991
K903287MODEL 900S APNEA/HEART MONITORAugust 17, 1990
K894030MODEL 37 UTERINE CONTRACTION ACTIVITY MONITORJanuary 22, 1990
K892006HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900SMay 23, 1989
K890150H-3000 OXYGEN CONCENTRATORJanuary 31, 1989
K881833NASAL CPAP SYSTEMJune 24, 1988
K875031OXYGEN/PULSE MONITORFebruary 12, 1988
K874814HEALTHDYNE RATE METERFebruary 11, 1988
K874695HEALTHDYNE APNEA/HEART MONITOR, MODEL 900January 29, 1988
K861484INFANT MONITORMay 21, 1986
K860254HEALTHDYNE'S EVENT RECORDER SYSTEMJanuary 30, 1986
K854374OXYGEN CONCENTRATOR, MODEL BX-5000January 3, 1986
K853300HEALTHDYNE IMPLUSE VENTILATORAugust 15, 1985
K843546INFANT MONITOR 16900October 10, 1984