Vitalograph Model 6000 Alpha

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 6000 Alpha.

Pre-market Notification Details

Device IDK212938
510k NumberK212938
Device Name:Vitalograph Model 6000 Alpha
ClassificationSpirometer, Diagnostic
Applicant Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare,  IE V95 Hft4
ContactTony O'hanlon
CorrespondentPaul Dryden
ProMedic Consulting LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-15
Decision Date2022-01-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05099169690028 K212938 000

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