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Infrasonics Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K943106ADULT VENTILATORDecember 28, 1995
K952878OXY/STAR LOW FLOW BLENDERSeptember 25, 1995
K934753STAR BREATHING CIRCUITSOctober 27, 1993
K922654VENTILATOR ADULT STAR MODIFICATIONDecember 1, 1992
K923704INFANT STAR SERIES 500October 22, 1992
K922477MODEL 105 VENTILATOR, MODIFICATIONAugust 24, 1992
K920954AIR STARAugust 3, 1992
K911804INFRASONICS VENTILATOR ADULT STAR, MODIFICATIONJune 11, 1992
K913972STAR SYNC, MODIFICATIONJanuary 9, 1992
K905272ADULT STAR, MODIFICATIONJanuary 30, 1991
K896825TRANSCUTANEOUS ELECTRONIC NERVE STIMULATORNovember 16, 1990
K895963MODIFIED STAR CALCMarch 16, 1990
K884521STAR SYNCJune 8, 1989
K875027STAR CALCAugust 16, 1988
K872466ADULT STARJuly 8, 1988
K873395HOYER SOLVETOctober 20, 1987
K853487PATIENT BREATHING CIRCUITSeptember 6, 1985
K842580ACCESSORY FOR ADULT VOL. VENTILATORAugust 24, 1984
K843036PATIENT BREATHING CIRCUITAugust 15, 1984
K840865INFANT STAR VENTILATORApril 30, 1984