ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY

Automated External Defibrillators (non-wearable)

ZELLER POWER PRODUCTS (BATTERY BEAST, LLC)

The following data is part of a premarket notification filed by Zeller Power Products (battery Beast, Llc) with the FDA for Zp9141, Zp9146y, Zp9146w Non-rechargeable Battery.

Pre-market Notification Details

Device IDK141231
510k NumberK141231
Device Name:ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZELLER POWER PRODUCTS (BATTERY BEAST, LLC) 3975 WEST POST ROAD Las Vegas,  NV  89118
ContactDouglas Austin
CorrespondentDouglas Austin
ZELLER POWER PRODUCTS (BATTERY BEAST, LLC) 3975 WEST POST ROAD Las Vegas,  NV  89118
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-13
Decision Date2014-11-25
Summary:summary

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