MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM— 510(k) K022506

Name: FDA 510(k) clearance K022506
Creator: U.S. Food and Drug Administration
Published: 2003-05-15

Substantially Equivalent

Widemed, Ltd.

FDA 510(k) clearance K022506 for MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM, Substantially Equivalent on 2003-05-15. Applicant: Widemed, Ltd.. Device class: 2.

Clearance details

Applicant: Widemed, Ltd.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2002-07-30
Decision date: 2003-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Omer, IL

Download summary PDF View on FDA.gov ↗

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