Medical Device Manufacturer · US , Walker , MI

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

33 submissions · 33 cleared · Since 1984

33

Total

33

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Aug 04, 2005

AMBU NEUROLINE GROUND

Neurology · 56d

Cleared Mar 05, 2004

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

Neurology · 225d