GALAXY— 510(k) K083874

Name: FDA 510(k) clearance K083874
Creator: U.S. Food and Drug Administration
Published: 2009-01-26

Substantially Equivalent

Respironics Inc., Sleep & Home Respiratory Group

FDA 510(k) clearance K083874 for GALAXY, Substantially Equivalent on 2009-01-26. Applicant: Respironics Inc., Sleep & Home Respiratory Group. Device class: 2.

Clearance details

Applicant: Respironics Inc., Sleep & Home Respiratory Group
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2008-12-29
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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