BREATH-TAKER BREATH-ALERT— 510(k) K953411

Name: FDA 510(k) clearance K953411
Creator: U.S. Food and Drug Administration
Published: 1996-06-13

Substantially Equivalent

Roxon - Universal Medical , Ltd.

FDA 510(k) clearance K953411 for BREATH-TAKER BREATH-ALERT, Substantially Equivalent on 1996-06-13. Applicant: Roxon - Universal Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Roxon - Universal Medical , Ltd.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 1995-07-20
Decision date: 1996-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Westminister, B.C., CA

Download summary PDF View on FDA.gov ↗

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