SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04— 510(k) K101286

Name: FDA 510(k) clearance K101286
Creator: U.S. Food and Drug Administration
Published: 2011-10-20

Substantially Equivalent

Linde Healthcare AB

FDA 510(k) clearance K101286 for SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04, Substantially Equivalent on 2011-10-20. Applicant: Linde Healthcare AB. Device class: 2.

Clearance details

Applicant: Linde Healthcare AB
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 2010-05-07
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lidingo, SE

Download summary PDF View on FDA.gov ↗

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