MODEL IPD OXYGEN CONSERVING DEVICE

Conserver, Oxygen

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Ipd Oxygen Conserving Device.

Pre-market Notification Details

Device IDK953852
510k NumberK953852
Device Name:MODEL IPD OXYGEN CONSERVING DEVICE
ClassificationConserver, Oxygen
Applicant INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria,  OH  44036
ContactEdward A Kroll
CorrespondentEdward A Kroll
INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria,  OH  44036
Product CodeNFB  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-16
Decision Date1995-11-22

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