ISO-GARD CLEARAIR MASK— 510(k) K123176

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K123176 for ISO-GARD CLEARAIR MASK, Substantially Equivalent on 2013-02-14. Applicant: Teleflexmedical, Inc.. Device class: 2.

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CBN
Device class: Class 2
Regulation: 21 CFR 868.5430
Advisory panel: Anesthesiology
Date received: 2012-10-10
Decision date: 2013-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, 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.