Model 9100 PFT/DICO

Calculator, Predicted Values, Pulmonary Function

Vitalograph Ireland Ltd.

The following data is part of a premarket notification filed by Vitalograph Ireland Ltd. with the FDA for Model 9100 Pft/dico.

Pre-market Notification Details

Device IDK221030
510k NumberK221030
Device Name:Model 9100 PFT/DICO
ClassificationCalculator, Predicted Values, Pulmonary Function
Applicant Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare,  IE V95 HFT4
ContactTony O'Hanlon
CorrespondentPaul Dryden
ProMedic, LLC 131 Bay Point Dr NE Saint Petersburg,  FL  33704
Product CodeBTY  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-07
Decision Date2022-07-15

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