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510(k) Data Aggregation
K Number
K240162Device Name
LIFEPAK® 35 AC Power Adapter (41335-000001)
Manufacturer
Stryker Physio-Control
Date Cleared
2024-04-19
(88 days)
Product Code
MPD
Regulation Number
870.5300Why did this record match?
Product Code :
MPD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf.
The LIFEPAK 35 AC power adapter is intended for indoor environments and for fixed installation in ground transportation vehicles.
Device Description
The LIFEPAK 35 AC Power Adapter is an optional accessory for use with only the LIFEPAK 35 monitor/defibrillator. This accessory contains: AC power adapter with output cable, mounting bracket, bracket screws, region-specific AC power cord (packed separately). The power adapter:
- Provides operating power to the monitor/defibrillator without batteries installed.
- Provides power to charge batteries installed in the monitor/ defibrillator.
The LIFEPAK 35 AC Power Adapter operates on 100 to 240 VAC line power. Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 35 monitor/defibrillator. To help manage and maintain battery charge, the power adapter should be kept plugged into the defibrillator whenever possible.
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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?
Product Code :
MPD
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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