Healthdyne Cardiovascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K901643ISOFLO(TM) AMNIOCENTESIS TRAYJuly 25, 1990
K901382ISOFLO(TM) HIGH PRESSURE INJECTION LINESJuly 19, 1990
K901084ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.June 1, 1990
K900665DRESSING CHANGE KITMay 14, 1990
K895763ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORINGDecember 22, 1989