MOBILE BATTERY SERVICE STATION (MBSS)

Automated External Defibrillators (non-wearable)

AD ELEKTRONIK GMBH

The following data is part of a premarket notification filed by Ad Elektronik Gmbh with the FDA for Mobile Battery Service Station (mbss).

Pre-market Notification Details

Device IDK030898
510k NumberK030898
Device Name:MOBILE BATTERY SERVICE STATION (MBSS)
ClassificationAutomated External Defibrillators (non-wearable)
Applicant AD ELEKTRONIK GMBH 33 STEEPLECHASE DR. Tunersville,  NJ  08012
ContactRichard Tootchen
CorrespondentRichard Tootchen
AD ELEKTRONIK GMBH 33 STEEPLECHASE DR. Tunersville,  NJ  08012
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-21
Decision Date2003-08-27
Summary:summary

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