SPIROVIT, MODEL SP-250

Spirometer, Diagnostic

SCHILLER AG

The following data is part of a premarket notification filed by Schiller Ag with the FDA for Spirovit, Model Sp-250.

Pre-market Notification Details

Device IDK984031
510k NumberK984031
Device Name:SPIROVIT, MODEL SP-250
ClassificationSpirometer, Diagnostic
Applicant SCHILLER AG ALTGASSE 68 Baar,  CH Ch-6341
ContactMarkus Buetler
CorrespondentMarkus Buetler
SCHILLER AG ALTGASSE 68 Baar,  CH Ch-6341
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-12
Decision Date1999-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613365000108 K984031 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.