WALLABY 4— 510(k) K070180

Name: FDA 510(k) clearance K070180
Creator: U.S. Food and Drug Administration
Published: 2007-05-18

Substantially Equivalent

Respironics Inc., Sleep & Home Respiratory Group

FDA 510(k) clearance K070180 for WALLABY 4, Substantially Equivalent on 2007-05-18. Applicant: Respironics Inc., Sleep & Home Respiratory Group. Device class: 2.

Clearance details

Applicant: Respironics Inc., Sleep & Home Respiratory Group
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2007-01-19
Decision date: 2007-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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