OSSTELL RESONANCE FREQUENCY ANALYZER— 510(k) K003714

Name: FDA 510(k) clearance K003714
Creator: U.S. Food and Drug Administration
Published: 2001-08-09

Substantially Equivalent

Integration Diagnostics, Ltd.

FDA 510(k) clearance K003714 for OSSTELL RESONANCE FREQUENCY ANALYZER, Substantially Equivalent on 2001-08-09. Applicant: Integration Diagnostics, Ltd.. Device class: 1.

Clearance details

Applicant: Integration Diagnostics, Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2000-12-01
Decision date: 2001-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, MN, US

Download summary PDF View on FDA.gov ↗

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