AMBU DISPOSABLE FACE MASK— 510(k) K932014

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K932014 for AMBU DISPOSABLE FACE MASK, Substantially Equivalent on 1993-06-22. Applicant: Ambu, Inc.. Device class: 1.

Clearance details

Applicant: Ambu, Inc.
Product code: Code BSJ
Device class: Class 1
Regulation: 21 CFR 868.5550
Advisory panel: Anesthesiology
Date received: 1993-04-23
Decision date: 1993-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linthicum, MD, 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.