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Biosound, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
39
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERJuly 9, 1997
K963936ACCESSPOINT, MED E-MAIL, DICOM READERMarch 31, 1997
K963262ARTOSCAN MMarch 28, 1997
K963662GALILEO EVOKED POTENTIALREFebruary 26, 1997
K953716INTRACAVITY TRANSDUCERSApril 17, 1996
K953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-AApril 8, 1996
K953819DIAGNOSTIC ULTRASOUND TRANDUCERMarch 1, 1996
K953759DIAGNOSTIC ULTRASOUND TRANSDUCERMarch 1, 1996
K955458ULTRASOUND PROBE BIOPSY ACCESSORIESFebruary 12, 1996
K953579TEE PROBEFebruary 2, 1996
K953430ULTRASOUND PROBE BIOPSY ACCESSORIESOctober 24, 1995
K941935LP-12 LAPAROSCOPIC PROBESeptember 18, 1995
K9442877050 ULTRASOUND IMAGING SYSTEMJune 2, 1995
K9444854000 AU ULTRASOUND IMAGING SYSTEMMay 24, 1995
K934050TOPOGRAPHIC BRAIN MAPPING OPTIONFebruary 3, 1994
K931022ARTOSCANOctober 7, 1993
K922703THE ACTA FORMULAApril 27, 1993
K923894YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPHMarch 10, 1993
K922488PHASIS ELECTROMYOGRAPHMarch 2, 1993
K923860THE GALILEO LINE -- PLANET 100, 200 & 300 & STARFebruary 4, 1993