MIR SPIROBANK SPIROMETER— 510(k) K983909

Name: FDA 510(k) clearance K983909
Creator: U.S. Food and Drug Administration
Published: 1998-12-21

Substantially Equivalent

Mir Medical Intl. Research Srl

FDA 510(k) clearance K983909 for MIR SPIROBANK SPIROMETER, Substantially Equivalent on 1998-12-21. Applicant: Mir Medical Intl. Research Srl. Device class: 2.

Clearance details

Applicant: Mir Medical Intl. Research Srl
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1998-11-03
Decision date: 1998-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albano Laziale, Roma, IT

Download summary PDF View on FDA.gov ↗

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