AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561

Automated External Defibrillators (non-wearable)

AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

The following data is part of a premarket notification filed by Amco International Manufacturing & Design, Inc. with the FDA for Amco Replacement Battery For Powerheart Aed, Non-rechargeable, Model 2l561; G3, Non-rechargable, Model 7l561.

Pre-market Notification Details

• Device ID: K082861
• 510k Number: K082861
• Device Name: AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
• Classification: Automated External Defibrillators (non-wearable)
• Applicant: AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT Elizabeth, CO 80107
• Contact: Alexander B Henderson Sr.
• Correspondent: Alexander B Henderson Sr.; AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. 377 ZANE COURT Elizabeth, CO 80107
• Product Code: MKJ
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-29
• Decision Date: 2008-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00865292000127	K082861	000
00853258006030	K082861	000
00853258006023	K082861	000
00853258006016	K082861	000