POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION

Humidifier, Respiratory Gas, (direct Patient Interface)

POROUS MEDIA CORP.

The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Humidiflow Humidifier For Universal Humidification.

Pre-market Notification Details

Device IDK062091
510k NumberK062091
Device Name:POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul,  MN  55110
ContactKeith A Roberts
CorrespondentNeil E Devine
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-07-24
Decision Date2006-08-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B462IP3 K062091 000

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