EASY BREATHER MODEL 100 ACCESSORIES

Ventilator, External Body, Negative Pressure, Adult (cuirass)

PROGRESSIVE PRODUCTIONS LTD.

The following data is part of a premarket notification filed by Progressive Productions Ltd. with the FDA for Easy Breather Model 100 Accessories.

Pre-market Notification Details

Device IDK902300
510k NumberK902300
Device Name:EASY BREATHER MODEL 100 ACCESSORIES
ClassificationVentilator, External Body, Negative Pressure, Adult (cuirass)
Applicant PROGRESSIVE PRODUCTIONS LTD. 70 ARCHWOOD DR. Mohrsville,  PA  19541
ContactM Bogusky
CorrespondentM Bogusky
PROGRESSIVE PRODUCTIONS LTD. 70 ARCHWOOD DR. Mohrsville,  PA  19541
Product CodeBYT  
CFR Regulation Number868.5935 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-23
Decision Date1990-07-19

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