INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE— 510(k) K040188

Name: FDA 510(k) clearance K040188
Creator: U.S. Food and Drug Administration
Published: 2004-04-14

Substantially Equivalent

Draeger Medical Systems, Inc.

FDA 510(k) clearance K040188 for INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE, Substantially Equivalent on 2004-04-14. Applicant: Draeger Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Draeger Medical Systems, Inc.
Product code: Code NHP
Device class: Class 2
Regulation: 21 CFR 868.1500
Advisory panel: Anesthesiology
Date received: 2004-01-28
Decision date: 2004-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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