510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032291Substantially Equivalent

Tosca Pco2, Spo2 and Pulse Rate Monitoring System

Linde Medical Sensors AG, Basel, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032291 is the FDA 510(k) clearance record for TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, a class II device, cleared for Linde Medical Sensors AG on under FDA product code DOA (Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.). FDA records list 4 510(k) clearances for Linde Medical Sensors AG, from to . As of , FDA records show no recalls naming K032291.

Clearance record

Decision date
Received
(397 days to decision)
Product code
DOA Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Linde Medical Sensors AG Austrasse 25, Basel, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DOA

Trailing 12 months

FDA records hold no clearances under product code DOA in the trailing twelve months.

FDA records show no clearances under product code DOA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DOA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260