SpiroHome Personal, SpiroHome Clinic— 510(k) K213754

Name: FDA 510(k) clearance K213754
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Substantially Equivalent

Inofab Saglik Teknolojileri A.S

FDA 510(k) clearance K213754 for SpiroHome Personal, SpiroHome Clinic, Substantially Equivalent on 2023-06-12. Applicant: Inofab Saglik Teknolojileri A.S. Device class: 2.

Clearance details

Applicant: Inofab Saglik Teknolojileri A.S
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2021-11-30
Decision date: 2023-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cankaya, Ankara, TR

Download summary PDF View on FDA.gov ↗

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