MODEL IRC 1001 AEROSOL COMPRESSOR

Nebulizer (direct Patient Interface)

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Irc 1001 Aerosol Compressor.

Pre-market Notification Details

Device IDK992643
510k NumberK992643
Device Name:MODEL IRC 1001 AEROSOL COMPRESSOR
ClassificationNebulizer (direct Patient Interface)
Applicant INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria,  OH  44036
ContactEdward A Kroll
CorrespondentEdward A Kroll
INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria,  OH  44036
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-06
Decision Date1999-10-27
Summary:summary

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