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FDA 510(k)

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A

K-Number: K091548 · 2009-08-07

ApplicantAmco International Manufacturing & Design, Inc.
Decision Date2009-08-07
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A 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 2009-08-07 under 510(k) number K091548. 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 PHILIPS MEDICAL MODELS BT1 AND M5070A?

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Amco International Manufacturing & Design, Inc.. The 510(k) number is K091548.

When did AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A receive FDA 510(k) clearance?

AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A received FDA 510(k) clearance on 2009-08-07, under 510(k) number K091548.

Who is the listed applicant for AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A?

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 PHILIPS MEDICAL MODELS BT1 AND M5070A?

The FDA product code for AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A is MKJ. This falls under the Dental category.

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.

K082861AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561K073716LIFE+CEL OR LIFECEL BATTERYK072596LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500K071164LIFE+CEL BATTERY

Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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.

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