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FDA 510(k)

LIFE+CEL BATTERY

K-Number: K071164 · 2007-12-07

ApplicantAmco International Manufacturing & Design, Inc.
Decision Date2007-12-07
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE+CEL BATTERY 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 2007-12-07 under 510(k) number K071164. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE+CEL BATTERY?

LIFE+CEL BATTERY is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Amco International Manufacturing & Design, Inc.. The 510(k) number is K071164.

When did LIFE+CEL BATTERY receive FDA 510(k) clearance?

LIFE+CEL BATTERY received FDA 510(k) clearance on 2007-12-07, under 510(k) number K071164.

Who is the listed applicant for LIFE+CEL BATTERY?

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 LIFE+CEL BATTERY?

The FDA product code for LIFE+CEL BATTERY is MHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Amco International Manufacturing & Design, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091548AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070AK082861AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561K073716LIFE+CEL OR LIFECEL BATTERYK072596LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500

Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Official Source

View on FDA Database →

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

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