Medical Device Manufacturer · US , Walker , MI

Biosensor Corp. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1983

Recent clearances: BIOSENSOR HOLTER MONITOR SYSTEM, BIOSENSOR HOLTER MONITOR SYSTEM

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biosensor Corp. Cardiovascular ✕

9 devices

1-9 of 9

Cleared Jun 14, 1999

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

Cardiovascular · 84d

Cleared Mar 04, 1998

BIOSENSOR HOLTER MONITOR SYSTEM

Cardiovascular · 117d

Cleared Mar 04, 1998

BIOSENSOR HOLTER MONITOR SYSTEM

Cardiovascular · 90d

Cleared Jun 18, 1996

AMBULATORY (HOLTER) RECORDING SYSTEM

Cardiovascular · 487d

Cleared May 30, 1996

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)

Cardiovascular · 121d

Cleared Feb 09, 1996

AMBULATORY (HOLTER) RECORDING SYSTEM

Cardiovascular · 358d

Cleared Feb 17, 1993

AMBULATORY (HOLTER) RECORDING, MODIFICATION

Cardiovascular · 328d

Cleared Jan 26, 1990

AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED

Cardiovascular · 156d

Cleared Dec 01, 1983

BIOSENSOR ASC SYSTEM

Cardiovascular · 192d