FDA 510(k)

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

K-Number: K082861 · 2008-11-25

ApplicantAmco International Manufacturing & Design, Inc.

Decision Date2008-11-25

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 is the device name listed in this FDA 510(k) record. The listed applicant is Amco International Manufacturing & Design, Inc.. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K082861. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Amco International Manufacturing & Design, Inc.. The 510(k) number is K082861.

When did AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 receive FDA 510(k) clearance?

AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 received FDA 510(k) clearance on 2008-11-25, under 510(k) number K082861.

Who is the listed applicant for AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561?

The FDA 510(k) record lists Amco International Manufacturing & Design, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561?

The FDA product code for AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 is MKJ. This falls under the Dental category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.