ECO CHECK (ECOVALVE AND OXYGEN MONITOR)

Generator, Oxygen, Portable

AIRSEP CORP.

The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Eco Check (ecovalve And Oxygen Monitor).

Pre-market Notification Details

Device IDK951882
510k NumberK951882
Device Name:ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
ClassificationGenerator, Oxygen, Portable
Applicant AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
ContactEwward E Vrana
CorrespondentEwward E Vrana
AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-03
Decision Date1995-10-16

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