FLOSENSE II, MODEL 29-8040— 510(k) K033939

Name: FDA 510(k) clearance K033939
Creator: U.S. Food and Drug Administration
Published: 2004-01-30

Substantially Equivalent

Sdi Diagnostics, Inc.

FDA 510(k) clearance K033939 for FLOSENSE II, MODEL 29-8040, Substantially Equivalent on 2004-01-30. Applicant: Sdi Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sdi Diagnostics, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2003-12-15
Decision date: 2004-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Easton, MA, US

Download summary PDF View on FDA.gov ↗

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