CALIBRATION KIT— 510(k) K911264

Substantially Equivalent

S & W Medico Teknik

FDA 510(k) clearance K911264 for CALIBRATION KIT, Substantially Equivalent on 1991-08-02. Applicant: S & W Medico Teknik. Device class: 1.

Clearance details

Applicant: S & W Medico Teknik
Product code: Code BXK
Device class: Class 1
Regulation: 21 CFR 868.6400
Advisory panel: Anesthesiology
Date received: 1991-03-11
Decision date: 1991-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denmark, DK

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K953934 — MED-TECH LUNG DIFFUSION MIXTURE1995-09-18

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