Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005906887

FEI Number

3005906887

Entity Name

AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

City/State/Country

Brooklyn, NY, US

Establishment Address

10 Conselyea Street, Brooklyn, NY 11211, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. (Owner Number: 9091903)

Owner / Operator Contact Address

10 CONSELYEA STREET, --, Brooklyn, NY 11211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K073716

PMA Number

N/A

All Registered Proprietary Names

AMCO AMCO AMCO AMCO AMCO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2009-09-16
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2009-09-16
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2009-09-14
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-09-16
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2009-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Similar Registrations

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3029871637	ZOLL International Holding B.V.	Elst Gelderland, NL
3015876	PHYSIO-CONTROL, INC.	Redmond, WA, US
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005906887. Last updated year: 2026. Please use registration number 3005906887 when referencing this establishment in official correspondence.