FDA 510(k)

Model 9100 PFT/DICO

K-Number: K221030 · 2022-07-15

Decision Date2022-07-15

Product CodeBTY

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Model 9100 PFT/DICO is a medical device manufactured by Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2022-07-15 under approval number K221030. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Model 9100 PFT/DICO?

Model 9100 PFT/DICO is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Vitalograph Ireland, Ltd.. The 510(k) number is K221030.

When was Model 9100 PFT/DICO approved by the FDA?

Model 9100 PFT/DICO received FDA 510(k) clearance on 2022-07-15, under approval number K221030.

What company makes Model 9100 PFT/DICO?

Model 9100 PFT/DICO is manufactured by Vitalograph Ireland, Ltd..

What is the FDA product code for Model 9100 PFT/DICO?

The FDA product code for Model 9100 PFT/DICO is BTY.

Other Devices by Vitalograph Ireland, Ltd.

K201562Spirotrac K200550Vitalograph Model 2120 In2itive eDiary K212938Vitalograph Model 6000 Alpha K223818Model 9160 VitaloQUB

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.