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510(k) Data Aggregation
K Number
K032051Device Name
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P
Manufacturer
ACCESS BATTERY, INC.
Date Cleared
2004-01-09
(191 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
ACCESS BATTERY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To power the functions of various devices for which batteries or battery packs are configured.
Since rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices,
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.
Device Description
Rechargeable batteries and battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical cquipment.
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K Number
K030261Device Name
BATTERY, RECHARGEABLE
Manufacturer
ACCESS BATTERY, INC.
Date Cleared
2003-04-24
(90 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
ACCESS BATTERY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power.
Device Description
Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power. These devices are copies of Original Equipment Manufacturer (OEM) or After-Market battery packs currently on the market. A sample is generally submitted by Hospitals, Medical Centers, and Biomedical or Clinical Engineering Service Professionals for duplication. Battery packs are "device specific" and are designed to operate and fit into those OEM devices for which they were manufactured.
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