VITALOGRAPH BASE STATION

Spirometer, Diagnostic

VITALOGRAPH, INC.

The following data is part of a premarket notification filed by Vitalograph, Inc. with the FDA for Vitalograph Base Station.

Pre-market Notification Details

Device IDK000599
510k NumberK000599
Device Name:VITALOGRAPH BASE STATION
ClassificationSpirometer, Diagnostic
Applicant VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa,  KS  66215
ContactPhil Hemes
CorrespondentPhil Hemes
VITALOGRAPH, INC. 8347 QUIVIRA RD. Lenexa,  KS  66215
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-22
Decision Date2000-09-08

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