THERA-MIST(TM) NEBULIZER, MODEL 30000

Nebulizer (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(tm) Nebulizer, Model 30000.

Pre-market Notification Details

Device IDK893942
510k NumberK893942
Device Name:THERA-MIST(TM) NEBULIZER, MODEL 30000
ClassificationNebulizer (direct Patient Interface)
Applicant PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa,  CA  92626
ContactKenneth G Miller
CorrespondentKenneth G Miller
PEGASUS RESEARCH CORP. 3001 REDHILL AVE., SUITE 4- 119 Costa Mesa,  CA  92626
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-31
Decision Date1989-08-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
612223310110 K893942 000
00612223030100 K893942 000
00612223030124 K893942 000
00612223030148 K893942 000
00612223030315 K893942 000
00612223030346 K893942 000
612223300005 K893942 000
612223300104 K893942 000
612223300111 K893942 000
612223300128 K893942 000
00612223300357 K893942 000
612223310103 K893942 000
00612223700010 K893942 000

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