510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043003Substantially Equivalent

Tcm40 Monitoring System

Radiometer Medical ApS, Bronshoj, DK / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043003 is the FDA 510(k) clearance record for TCM40 MONITORING SYSTEM, a class II device, cleared for Radiometer Medical Aps on under FDA product code LKD (Monitor, Carbon-Dioxide, Cutaneous). FDA records list 30 510(k) clearances for Radiometer Medical Aps, from to . As of , FDA records show 3 recalls naming K043003.

Clearance record

Decision date
Received
(120 days to decision)
Product code
LKD Monitor, Carbon-Dioxide, Cutaneous
Regulation
21 CFR 868.2480
Device class
Class II
Review panel
Anesthesiology
Applicant
Radiometer Medical Aps Akandevej 21 Dk-2700, Bronshoj, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKD

Trailing 12 months

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

FDA records show no clearances under product code LKD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKD, 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