Amco International Manufacturing & Design, Inc.
Brooklyn, NY, US
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. appears in FDA device records in Brooklyn, NY. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Amco International Manufacturing & Design, Inc. between 2007 and 2009. The busiest year on record is 2008, with 3. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A | MKJ | Substantially Equivalent | |
| K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 | MKJ | Substantially Equivalent | |
| K073716 | LIFE+CEL OR LIFECEL BATTERY | MKJ | Substantially Equivalent | |
| K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | MKJ | Substantially Equivalent | |
| K071164 | LIFE+CEL BATTERY | MHX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005906887 | 3005906887 | AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. | 10 Conselyea Street, Brooklyn, NY 11211 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Amco International Manufacturing & Design, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain