VENTURI VENTILATOR

Ventilator, Continuous, Facility Use

CARDIOPULMONARY CORP.

The following data is part of a premarket notification filed by Cardiopulmonary Corp. with the FDA for Venturi Ventilator.

Pre-market Notification Details

Device IDK982174
510k NumberK982174
Device Name:VENTURI VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford,  CT  06460
ContactJames W Biondi
CorrespondentJames W Biondi
CARDIOPULMONARY CORP. 200 CASCADE BLVD. Milford,  CT  06460
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-17
Decision Date1998-06-24

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