K083874

Substantially Equivalent

GALAXY

Applicant: Respironics Inc., Sleep & Home Respiratory Group
Product code: MNR
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.