SPIROBANK II— 510(k) K061712

Substantially Equivalent

Mir Medical Intl. Research Srl

FDA 510(k) clearance K061712 for SPIROBANK II, Substantially Equivalent on 2006-12-01. 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: 2006-06-19
Decision date: 2006-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 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.