Medical Device Manufacturer · US , Burlington , MA

Fasstech - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1993

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fasstech Neurology ✕

9 devices

1-9 of 9

Cleared Aug 16, 2007

INSIGHT DISCOVERY

Neurology · 274d

Cleared Nov 28, 2003

Neurology · 29d

Cleared Oct 10, 2003

INSIGHT MILLENNIUM III

Neurology · 379d

Cleared Sep 20, 2001

INSIGHT MILLENNIUM PLUS

Neurology · 87d

Cleared Aug 30, 2001

INSIGHT GENESIS

Neurology · 65d

Cleared Jun 03, 1999

INSIGHT MILLENNIUM

Neurology · 86d

Cleared Jun 12, 1996

Neurology · 76d

Cleared Feb 24, 1995

Neurology · 415d

Cleared Feb 02, 1993

PSI 220 DUAL EMG

Neurology · 110d