Medical Device Manufacturer · CA , St.Laurent, Quebec

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

5 submissions · 5 cleared · Since 2000

5

Total

5

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Oct 01, 2002

BIOLOGICAL SOUND MONITOR (BSM) SENSOR

Cardiovascular · 152d

Cleared Oct 01, 2002

Cardiovascular · 77d

Cleared Oct 26, 2001

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A

Cardiovascular · 228d

Cleared Jul 20, 2000

STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

Cardiovascular · 86d