PATIENT VENTILATOR ISOLATOR

Ventilator, Continuous, Facility Use

DRYDEN CORP.

The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Patient Ventilator Isolator.

Pre-market Notification Details

Device IDK880923
510k NumberK880923
Device Name:PATIENT VENTILATOR ISOLATOR
ClassificationVentilator, Continuous, Facility Use
Applicant DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis,  IN  46236
ContactPaul E Dryden
CorrespondentPaul E Dryden
DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis,  IN  46236
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-04
Decision Date1988-09-06

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