THERA-MIST HUMIDIFIER

Humidifier, Respiratory Gas, (direct Patient Interface)

PEGASUS RESEARCH CORP.

The following data is part of a premarket notification filed by Pegasus Research Corp. with the FDA for Thera-mist Humidifier.

Pre-market Notification Details

Device IDK894000
510k NumberK894000
Device Name:THERA-MIST HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa,  CA  92626
ContactKenneth Miller
CorrespondentKenneth Miller
PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa,  CA  92626
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-05
Decision Date1989-08-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
612223035006 K894000 000
00612223013103 K894000 000
00612223001339 K894000 000
00612223001315 K894000 000

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