PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT— 510(k) K050166

Name: FDA 510(k) clearance K050166
Creator: U.S. Food and Drug Administration
Published: 2005-05-26

Substantially Equivalent

Smiths Medical

FDA 510(k) clearance K050166 for PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT, Substantially Equivalent on 2005-05-26. Applicant: Smiths Medical. Device class: 2.

Clearance details

Applicant: Smiths Medical
Product code: Code BWC
Device class: Class 2
Regulation: 21 CFR 868.5090
Advisory panel: Anesthesiology
Date received: 2005-01-26
Decision date: 2005-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hythe, Kent, GB

Download summary PDF View on FDA.gov ↗

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