SCHILLER MODEL SP-200 SPIROVIT(TM)

Spirometer, Diagnostic

SCHILLER AMERICA, INC.

The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Schiller Model Sp-200 Spirovit(tm).

Pre-market Notification Details

Device IDK896121
510k NumberK896121
Device Name:SCHILLER MODEL SP-200 SPIROVIT(TM)
ClassificationSpirometer, Diagnostic
Applicant SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin,  CA  92680
ContactGodfrey J Fletcher
CorrespondentGodfrey J Fletcher
SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin,  CA  92680
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-24
Decision Date1990-01-09

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