TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM— 510(k) K032291

Name: FDA 510(k) clearance K032291
Creator: U.S. Food and Drug Administration
Published: 2004-08-24

Substantially Equivalent

Linde Medical Sensors AG

FDA 510(k) clearance K032291 for TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, Substantially Equivalent on 2004-08-24. Applicant: Linde Medical Sensors AG. Device class: 2.

Clearance details

Applicant: Linde Medical Sensors AG
Product code: Code DOA
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2003-07-24
Decision date: 2004-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

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