AUSTIN INHALATOR— 510(k) K823246

Substantially Equivalent

Ems Industries, Inc.

FDA 510(k) clearance K823246 for AUSTIN INHALATOR, Substantially Equivalent on 1982-12-16. Applicant: Ems Industries, Inc.. Device class: 1.

Clearance details

Applicant: Ems Industries, Inc.
Product code: Code BYX
Device class: Class 1
Regulation: 21 CFR 868.5860
Advisory panel: Anesthesiology
Date received: 1982-11-01
Decision date: 1982-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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