Medical Device Manufacturer · US , Portsmouth , NH

The Prometheus Group - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1991

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - The Prometheus Group Neurology ✕

4 devices

1-4 of 4

Cleared Dec 17, 1997

PATHWAY ELECTROMYOGRAPH

Neurology · 90d

Cleared Aug 07, 1996

PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20

Neurology · 163d

Cleared Jun 13, 1996

Neurology · 108d

Cleared Apr 18, 1991

PATHWAY II ELECTROMYOGRAPH

Neurology · 477d