SPIRO-BALL

Spirometer, Therapeutic (incentive)

LEVENTON, S.A.

The following data is part of a premarket notification filed by Leventon, S.a. with the FDA for Spiro-ball.

Pre-market Notification Details

Device IDK053149
510k NumberK053149
Device Name:SPIRO-BALL
ClassificationSpirometer, Therapeutic (incentive)
Applicant LEVENTON, S.A. C/NEWTON 18-24, POLIGONO INDUSTRIAL SESROVIRES, SANT Esteve Sesrovires, Barcelona,  ES 08635
ContactOriol Vernis
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-11-10
Decision Date2005-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18436020761840 K053149 000

Trademark Results [SPIRO-BALL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIRO-BALL
SPIRO-BALL
79107544 4169867 Dead/Cancelled
LEVENTON S.A.
2011-12-02
SPIRO-BALL
SPIRO-BALL
75292230 not registered Dead/Abandoned
Kennedy, Robert H. Sr.
1997-05-15

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