450SLL DEFIBRILLATOR

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

MEDICAL RESEARCH LABORATORIES, INC.

The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for 450sll Defibrillator.

Pre-market Notification Details

Device IDK874204
510k NumberK874204
Device Name:450SLL DEFIBRILLATOR
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST. Niles,  IL  60648
ContactDilip Mehta
CorrespondentDilip Mehta
MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST. Niles,  IL  60648
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-15
Decision Date1988-01-28

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