Medical Device Manufacturer · US , Mansfield , MA

Bio-Detek, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1985

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio-Detek, Inc. Neurology ✕

2 devices

1-2 of 2

Cleared Aug 14, 1992

BIO-DETEK EEG ELECTRODE

Neurology · 200d

Cleared Jun 02, 1992

BIO-DETEK TRACERITE EEG ELECTRODE

Neurology · 133d