SMDIA-1000

Nebulizer (direct Patient Interface)

SOUTHMEDIC, INC.

The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Smdia-1000.

Pre-market Notification Details

Device IDK101953
510k NumberK101953
Device Name:SMDIA-1000
ClassificationNebulizer (direct Patient Interface)
Applicant SOUTHMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
SOUTHMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-12
Decision Date2011-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10620974001697 K101953 000
10620974001673 K101953 000
10620974001666 K101953 000
10620974001635 K101953 000
10620974001109 K101953 000

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