METALYZER, MODEL 2; METALYZER, MODEL 3— 510(k) K993641

Name: FDA 510(k) clearance K993641
Creator: U.S. Food and Drug Administration
Published: 2000-12-14

Substantially Equivalent

Cortex Biophysik GmbH

FDA 510(k) clearance K993641 for METALYZER, MODEL 2; METALYZER, MODEL 3, Substantially Equivalent on 2000-12-14. Applicant: Cortex Biophysik GmbH. Device class: 2.

Clearance details

Applicant: Cortex Biophysik GmbH
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1999-10-28
Decision date: 2000-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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