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Air-Shields, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMOctober 7, 1998
K972309JM-102 JAUNDICE METERSeptember 22, 1998
K971256DUO-LITE PHOTOTHERAPY SYSTEMSeptember 24, 1997
K960980ISOLETTE INFANT INCUBATORJuly 30, 1996
K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEJanuary 17, 1996
K940951RW RESUCITAIRE INFANT RADIANT WARMERMay 3, 1995
K940975C450/C400 INFANT INCUBATORSJune 23, 1994
K941106MODEL TI500 ISOLETTE INFANT INCUBATORJune 10, 1994
K924170ISOLETTE INCUBATOR HUMIDITY METERFebruary 5, 1993
K922150EXAMINATION LAMPJuly 21, 1992
K914864MODELS C500/C550 ISOLETE(R) INFANT INCUBATORMarch 13, 1992
K913291MODEL C386 ISOLETTE(R) INFANT INCUBATORNovember 13, 1991
K874326SYSTEM VI MONITORDecember 5, 1988
K880781DATALOGGER CHART RECORDERMay 11, 1988
K875270INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUSJanuary 19, 1988
K872742WARM WEIGH MODELS I-20/W-30 INFANT SCALEOctober 20, 1987
K871594BIRTHING ROOM WARMERJune 5, 1987
K870888WARM WEIGH MODEL N-10 INFANT SCALEMarch 17, 1987
K861781DELIVERY ROOM WARMERJuly 15, 1986
K861743AS165 RESPIRATION MONITORMay 9, 1986