STERITEC EMU-GRAPH, MODEL NO. CI 131/US— 510(k) K040901

Name: FDA 510(k) clearance K040901
Creator: U.S. Food and Drug Administration
Published: 2004-09-09

Substantially Equivalent

Steritec Products, Inc.

FDA 510(k) clearance K040901 for STERITEC EMU-GRAPH, MODEL NO. CI 131/US, Substantially Equivalent on 2004-09-09. Applicant: Steritec Products, Inc.. Device class: 2.

Clearance details

Applicant: Steritec Products, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2004-04-07
Decision date: 2004-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castle Rock, CO, US

Download summary PDF View on FDA.gov ↗

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