Medical Device Manufacturer · US , Elizabeth , CO

Amco International Manufacturing & Design, Inc. - FDA 510(k) Cleared ...

5 submissions · 5 cleared · Since 2007

Recent clearances: AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A, AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561, LIFE+CEL OR LIFECEL BATTERY

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amco International Manufacturing & Design, Inc. Cardiovascular ✕

5 devices

1-5 of 5

Cleared Aug 07, 2009

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A

Cardiovascular · 72d

Cleared Nov 25, 2008

AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561

Cardiovascular · 57d

Cleared Apr 11, 2008

LIFE+CEL OR LIFECEL BATTERY

Cardiovascular · 102d

Cleared Jan 24, 2008

LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500

Cardiovascular · 132d

Cleared Dec 07, 2007

LIFE+CEL BATTERY

Cardiovascular · 225d