Spirotrac— 510(k) K201562

Substantially Equivalent

Vitalograph Ireland, Ltd.

FDA 510(k) clearance K201562 for Spirotrac, Substantially Equivalent on 2020-10-14. Applicant: Vitalograph Ireland, Ltd.. Device class: 2.

Clearance details

Applicant: Vitalograph Ireland, Ltd.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2020-06-10
Decision date: 2020-10-14
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.