AS/3 AIRWAY MODULE— 510(k) K943458

Name: FDA 510(k) clearance K943458
Creator: U.S. Food and Drug Administration
Published: 1995-02-14

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K943458 for AS/3 AIRWAY MODULE, Substantially Equivalent on 1995-02-14. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code CBS
Device class: Class 2
Regulation: 21 CFR 868.1620
Advisory panel: Anesthesiology
Date received: 1994-07-18
Decision date: 1995-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

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