SPIROTEL— 510(k) K130784

Substantially Equivalent

Mir Medical Intl. Research Srl

FDA 510(k) clearance K130784 for SPIROTEL, Substantially Equivalent on 2013-10-30. 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: 2013-03-21
Decision date: 2013-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Roma, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Mir Medical Intl. Research Srl

K122384 — MINISPIR2012-10-04
K081033 — MIROXI2009-01-15
K082766 — MODIFICATION TO MINISPIR, SPIROLAB III2008-12-17
K072979 — SPIROBANK G2007-12-26
K061875 — MINISPIR; SPIROLAB III2006-12-11

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