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Air-Shields, Inc.

FDA Regulatory Profile

Air-Shields, Inc. has 0 FDA recalls, 0 inspections, 33 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 7, 1998

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances33Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMOct 7, 1998
K972309JM-102 JAUNDICE METERSep 22, 1998
K971256DUO-LITE PHOTOTHERAPY SYSTEMSep 24, 1997
K960980ISOLETTE INFANT INCUBATORJul 30, 1996
K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEJan 17, 1996
K940951RW RESUCITAIRE INFANT RADIANT WARMERMay 3, 1995
K940975C450/C400 INFANT INCUBATORSJun 23, 1994
K941106MODEL TI500 ISOLETTE INFANT INCUBATORJun 10, 1994
K924170ISOLETTE INCUBATOR HUMIDITY METERFeb 5, 1993
K922150EXAMINATION LAMPJul 21, 1992
K914864MODELS C500/C550 ISOLETE(R) INFANT INCUBATORMar 13, 1992
K913291MODEL C386 ISOLETTE(R) INFANT INCUBATORNov 13, 1991
K874326SYSTEM VI MONITORDec 5, 1988
K880781DATALOGGER CHART RECORDERMay 11, 1988
K875270INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUSJan 19, 1988
K872742WARM WEIGH MODELS I-20/W-30 INFANT SCALEOct 20, 1987
K871594BIRTHING ROOM WARMERJun 5, 1987
K870888WARM WEIGH MODEL N-10 INFANT SCALEMar 17, 1987
K861781DELIVERY ROOM WARMERJul 15, 1986
K861743AS165 RESPIRATION MONITORMay 9, 1986

FDA data resources