Belun Sleep System BLS-100— 510(k) K222579

Name: FDA 510(k) clearance K222579
Creator: U.S. Food and Drug Administration
Published: 2023-02-23

Substantially Equivalent

Belun Technology Company Limited

FDA 510(k) clearance K222579 for Belun Sleep System BLS-100, Substantially Equivalent on 2023-02-23. Applicant: Belun Technology Company Limited. Device class: 2.

Clearance details

Applicant: Belun Technology Company Limited
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2022-08-25
Decision date: 2023-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sha Tin, CN

Download summary PDF View on FDA.gov ↗

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