SPL-50 SPIROLYSER— 510(k) K010761

Substantially Equivalent

Fim Medical

FDA 510(k) clearance K010761 for SPL-50 SPIROLYSER, Substantially Equivalent on 2002-03-05. Applicant: Fim Medical. Device class: 2.

Clearance details

Applicant: Fim Medical
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2001-03-13
Decision date: 2002-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lyon, FR

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 Fim Medical

K161676 — Q13 SPIROLYSER®2016-10-20
K080278 — TABATABA COTESTER2008-11-28
K050424 — ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-502005-06-23

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