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. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Sep 22, 2004

AMBU DISPOSABLE ECG ELECTRODE

Cardiovascular · 89d

Cleared Jun 28, 2004

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

Cardiovascular · 68d

Cleared Feb 27, 2004

AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE

Cardiovascular · 206d