BLEASE 6200 ANAESTHESIA VENTILATOR

Ventilator, Continuous, Facility Use

BLEASE MEDICAL EQUIPMENT LTD.

The following data is part of a premarket notification filed by Blease Medical Equipment Ltd. with the FDA for Blease 6200 Anaesthesia Ventilator.

Pre-market Notification Details

Device IDK982132
510k NumberK982132
Device Name:BLEASE 6200 ANAESTHESIA VENTILATOR
ClassificationVentilator, Continuous, Facility Use
Applicant BLEASE MEDICAL EQUIPMENT LTD. 12601 RESEARCH PKWY. ATT: FRANCIS X CASEY Orlando,  FL  32826
ContactFrancis X Casey
CorrespondentFrancis X Casey
BLEASE MEDICAL EQUIPMENT LTD. 12601 RESEARCH PKWY. ATT: FRANCIS X CASEY Orlando,  FL  32826
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-17
Decision Date1999-04-15

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