DEFI 2

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

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Defi 2.

Pre-market Notification Details

Device IDK851931
510k NumberK851931
Device Name:DEFI 2
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant S & W MEDICO TEKNIK 1819 H. ST. NW FEDERAL BAR BLDG. Washington,  DC  20006
ContactJes Petersen
CorrespondentJes Petersen
S & W MEDICO TEKNIK 1819 H. ST. NW FEDERAL BAR BLDG. Washington,  DC  20006
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-02
Decision Date1985-08-05

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