Cleared Traditional

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009

K043357 · Linde Medical Sensors AG · Anesthesiology
Mar 2005
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K043357 is an FDA 510(k) clearance for the TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009, a Monitor, Carbon-dioxide, Cutaneous (Class II — Special Controls, product code LKD), submitted by Linde Medical Sensors AG (Basel, CH). The FDA issued a Cleared decision on March 4, 2005, 88 days after receiving the submission on December 6, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2480.

Submission Details

510(k) Number K043357 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2004
Decision Date March 04, 2005
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code LKD — Monitor, Carbon-dioxide, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2480

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