VOLUMETRIC INCENTIVE SPIROMETER— 510(k) K141355

Name: FDA 510(k) clearance K141355
Creator: U.S. Food and Drug Administration
Published: 2014-09-03

Substantially Equivalent

Besmed Health Business Corporation

FDA 510(k) clearance K141355 for VOLUMETRIC INCENTIVE SPIROMETER, Substantially Equivalent on 2014-09-03. Applicant: Besmed Health Business Corporation. Device class: 2.

Clearance details

Applicant: Besmed Health Business Corporation
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2014-05-23
Decision date: 2014-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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