TRIBALL INCENTIVE SPIROMETER— 510(k) K133873

Name: FDA 510(k) clearance K133873
Creator: U.S. Food and Drug Administration
Published: 2014-04-04

Substantially Equivalent

Besmed Health Business Corp

FDA 510(k) clearance K133873 for TRIBALL INCENTIVE SPIROMETER, Substantially Equivalent on 2014-04-04. Applicant: Besmed Health Business Corp. Device class: 2.

Clearance details

Applicant: Besmed Health Business Corp
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2013-12-20
Decision date: 2014-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, Wu-Ku District, TW

Download summary PDF View on FDA.gov ↗

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