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510(k) Data Aggregation
K Number
K062331Device Name
HIGHPAK-12
Manufacturer
AD ELEKTRONIK GMBH
Date Cleared
2007-07-10
(334 days)
Product Code
MPD
Regulation Number
870.5300Why did this record match?
Applicant Name (Manufacturer) :
AD ELEKTRONIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HighPak® -12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
Device Description
The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.
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K Number
K030898Device Name
MOBILE BATTERY SERVICE STATION (MBSS)
Manufacturer
AD ELEKTRONIK GMBH
Date Cleared
2003-08-27
(159 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
AD ELEKTRONIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic - Physio Control.
Device Description
The MBSS overall dimensions are 30 cm x 20 cm x 10 cm. It is available either as a table top model or wall mount unit. The table top model has a standard power cord which plugs into a 110 volt wall outlet and non-slip rubberized feet. The wall mount model has a bracket for mounting the charger on a vertical surface. For mounting and use in an automobile (ambulance or rescue vehicle), the wall mount bracket is used. Power requirements are either standard mains at 120 volts or standard automotive 12 volts. The charger is only used for charging specific batteries. The batteries are removed from the defibrillator and inserted into the MBSS charging bays. The MBSS is not attached to the defibrillator during operation.
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