Data / Medical devices / United States / Amco International Manufacturing & Design, Inc.
Amco International Manufacturing & Design, Inc.: FDA-registered device maker in Brooklyn, NY, United States, 5 510(k) clearances
Amco International Manufacturing & Design, Inc. is registered with the FDA (registration 3005906887) in Brooklyn, NY, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 7, 2009. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005906887
- Address
- 10 Conselyea Street, Brooklyn, NY, United States, 11211
- Owner or operator
- AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. (9091903)
- Roles
- Manufacturer
- First device listed
- September 6, 2006
- Registered through
- 2026
- Brand names listed
- AMCO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Manufacturer | accessdata.fda.gov |
| MOX | MOX | Manufacturer | accessdata.fda.gov | |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2009 | K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A | MKJ | Substantially Equivalent | Amco International Manufacturing & Design, Inc. | accessdata.fda.gov |
| November 25, 2008 | K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 | MKJ | Substantially Equivalent | Amco International Manufacturing & Design, Inc. | accessdata.fda.gov |
| April 11, 2008 | K073716 | LIFE+CEL OR LIFECEL BATTERY | MKJ | Substantially Equivalent | Amco International Manufacturing & Design, Inc. | accessdata.fda.gov |
| January 24, 2008 | K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | MKJ | Substantially Equivalent | Amco International Manufacturing & Design, Inc. | accessdata.fda.gov |
| December 7, 2007 | K071164 | LIFE+CEL BATTERY | MHX | Substantially Equivalent | Amco International Manufacturing & Design, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated External Defibrillators (Non-Wearable)
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Updated August 7, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.