Medical Device Manufacturer · US , Southbridge , MA

Aearo Company - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2006

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aearo Company General Hospital ✕

3 devices

1-3 of 3

Cleared Nov 08, 2007

AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C

General Hospital · 78d

Cleared Apr 18, 2007

N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C

General Hospital · 90d

Cleared Dec 01, 2006

PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S

General Hospital · 60d