BREATHE EASY, MODELS AD AND CD— 510(k) K981841

Name: FDA 510(k) clearance K981841
Creator: U.S. Food and Drug Administration
Published: 1998-10-13

Substantially Equivalent

Respiraid , Ltd.

FDA 510(k) clearance K981841 for BREATHE EASY, MODELS AD AND CD, Substantially Equivalent on 1998-10-13. Applicant: Respiraid , Ltd.. Device class: 2.

Clearance details

Applicant: Respiraid , Ltd.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 1998-05-26
Decision date: 1998-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, IL

Download summary PDF View on FDA.gov ↗

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