MINISPIR— 510(k) K122384

Substantially Equivalent

Mir Medical Intl. Research Srl

FDA 510(k) clearance K122384 for MINISPIR, Substantially Equivalent on 2012-10-04. 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: 2012-08-06
Decision date: 2012-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Roma, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZG

K251777 — MESI mTABLET SPIRO2026-03-02
K241843 — TD-7301 Spirometer (TD-7301)2024-11-20
K231416 — Air Next (NVD-02)2024-01-18
K230501 — Spirobank Oxi2023-12-15
K230178 — EasyOne Sky Spirometer2023-10-19

More clearances from Mir Medical Intl. Research Srl

K130784 — SPIROTEL2013-10-30
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.