VITALOGRAPH-ALPHA

Spirometer, Diagnostic

VITALOGRAPH LTD.

The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph-alpha.

Pre-market Notification Details

Device IDK873562
510k NumberK873562
Device Name:VITALOGRAPH-ALPHA
ClassificationSpirometer, Diagnostic
Applicant VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
ContactLovina G Freeman
CorrespondentLovina G Freeman
VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-02
Decision Date1988-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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