Medical Device Manufacturer · US , Indianapolis , IN

Biosound, Inc. - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 1983

Recent clearances: BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER, ACCESSPOINT, MED E-MAIL, DICOM READER, ARTOSCAN M

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biosound, Inc. Neurology ✕

6 devices

1-6 of 6

Cleared Feb 26, 1997

GALILEO EVOKED POTENTIALRE

Neurology · 166d

Cleared Feb 03, 1994

TOPOGRAPHIC BRAIN MAPPING OPTION

Neurology · 168d

Cleared Mar 10, 1993

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH

Neurology · 218d

Cleared Mar 02, 1993

PHASIS ELECTROMYOGRAPH

Neurology · 279d

Cleared Feb 04, 1993

THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR

Neurology · 188d

Cleared Jan 26, 1993

THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH

Neurology · 174d