VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

Spirometer, Diagnostic

VITALOGRAPH(IRELAND) LTD.

The following data is part of a premarket notification filed by Vitalograph(ireland) Ltd. with the FDA for Vitalograph Model 4000 (asma-1 And Copd-6).

Pre-market Notification Details

Device IDK073155
510k NumberK073155
Device Name:VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
ClassificationSpirometer, Diagnostic
Applicant VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD Ennis, Co. Clare,  IE
ContactTom J Healy
CorrespondentTom J Healy
VITALOGRAPH(IRELAND) LTD. ENNIS INDUSTRIAL ESTATE GORT ROAD Ennis, Co. Clare,  IE
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-08
Decision Date2008-06-04
Summary:summary

NIH GUDID Devices

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