ESCORT 300 SERIES

Dc-defibrillator, Low-energy, (including Paddles)

MEDICAL DATA ELECTRONICS

The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort 300 Series.

Pre-market Notification Details

Device IDK911665
510k NumberK911665
Device Name:ESCORT 300 SERIES
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta,  CA  91331
ContactChip Harlow
CorrespondentChip Harlow
MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta,  CA  91331
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-12
Decision Date1991-08-29

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