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

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..

Clearance details

Applicant: Roxon - Universal Medical , Ltd.
Product code: Code BZH
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

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