Medical Device Manufacturer · US , Indianapolis , IN

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

39 submissions · 39 cleared · Since 1983

39

Total

39

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Apr 27, 1993

THE ACTA FORMULA

Cardiovascular · 326d

Cleared Nov 04, 1992

PERSONAL 120/210 LAPTOP STRESS OPTION

Cardiovascular · 173d

Cleared Mar 17, 1992

ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS

Cardiovascular · 49d

Cleared Jan 29, 1990

GENESIS III, (MOD. 7003/7004)

Cardiovascular · 199d

Cleared Aug 12, 1988

GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER

Cardiovascular · 113d

Cleared May 20, 1988

BIOSOUND MMI ULTRASOUND

Cardiovascular · 403d

Cleared Feb 18, 1988

GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN

Cardiovascular · 198d

Cleared Nov 06, 1987

Cardiovascular · 190d

Cleared Feb 02, 1987

EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND

Cardiovascular · 188d

Cleared Nov 10, 1986

HIGH VELOCITY CW DOPPLER SYSTEM

Cardiovascular · 104d