Cleared Traditional

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

K032291 · Linde Medical Sensors AG · Toxicology
Aug 2004
Decision
397d
Days
Class 2
Risk

About This 510(k) Submission

K032291 is an FDA 510(k) clearance for the TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, a Radioimmunoassay, Digoxin (125-i), Goat Antibody, Anion Exchange, Resin Sep. (Class II — Special Controls, product code DOA), submitted by Linde Medical Sensors AG (Basel, CH). The FDA issued a Cleared decision on August 24, 2004, 397 days after receiving the submission on July 24, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K032291 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2003
Decision Date August 24, 2004
Days to Decision 397 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DOA — Radioimmunoassay, Digoxin (125-i), Goat Antibody, Anion Exchange, Resin Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320