Breezing Med— 510(k) K200076

Substantially Equivalent

Tf Health Co.

FDA 510(k) clearance K200076 for Breezing Med, Substantially Equivalent on 2020-09-25. Applicant: Tf Health Co.. Device class: 2.

Clearance details

Applicant: Tf Health Co.
Product code: Code BZL
Device class: Class 2
Regulation: 21 CFR 868.1730
Advisory panel: Anesthesiology
Date received: 2020-01-14
Decision date: 2020-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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