THERA-MIST NEBULIZER MODEL-P3000

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 Nebulizer Model-p3000.

Pre-market Notification Details

Device IDK962534
510k NumberK962534
Device Name:THERA-MIST NEBULIZER MODEL-P3000
ClassificationNebulizer (direct Patient Interface)
Applicant PEGASUS RESEARCH CORP. 2003 SOUTH RITCHEY AVE. Santa Ana,  CA  92705
ContactMichael Hennigman
CorrespondentMichael Hennigman
PEGASUS RESEARCH CORP. 2003 SOUTH RITCHEY AVE. Santa Ana,  CA  92705
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-28
Decision Date1997-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
612223310226 K962534 000
00612223030254 K962534 000
00612223030278 K962534 000
00612223030322 K962534 000
612223030216 K962534 000
00612223300258 K962534 000
612223300210 K962534 000
612223300227 K962534 000
612223300234 K962534 000
00612223300296 K962534 000
612223300319 K962534 000
00612223310257 K962534 000
00612223310264 K962534 000
00612223030230 K962534 000

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