MODEL LP6 VENTILATOR, MODIFICATION

Ventilator, Continuous, Facility Use

AEQUITRON MEDICAL, INC.

The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model Lp6 Ventilator, Modification.

Pre-market Notification Details

Device IDK905244
510k NumberK905244
Device Name:MODEL LP6 VENTILATOR, MODIFICATION
ClassificationVentilator, Continuous, Facility Use
Applicant AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis,  MN  55447 -4834
ContactKenneth B Herland
CorrespondentKenneth B Herland
AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis,  MN  55447 -4834
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-20
Decision Date1990-11-30

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