Medical Device Manufacturer · US , West Warwick , RI

Astro-Med, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1989

13

Total

13

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Dec 24, 2008

TWIN NEUROTRAC-III

Neurology · 204d

Cleared Oct 20, 2005

Neurology · 244d

Cleared Feb 18, 2004

Neurology · 57d

Cleared May 19, 1997

GRASS BRAINWAVE SOFTWARE

Neurology · 66d

Cleared Dec 12, 1996

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM

Neurology · 90d

Cleared Jan 22, 1990

ASC-954 INTEGRATOR AMPLIFIER

Neurology · 90d