Model 9100 PFT/DICO— 510(k) K221030

Substantially Equivalent

Vitalograph Ireland, Ltd.

FDA 510(k) clearance K221030 for Model 9100 PFT/DICO, Substantially Equivalent on 2022-07-15. Applicant: Vitalograph Ireland, Ltd.. Device class: 2.

Clearance details

Applicant: Vitalograph Ireland, Ltd.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2022-04-07
Decision date: 2022-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ennis Co Clare, IE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.