510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041956Substantially Equivalent

EMG - Essential Gas Module, Model M1013a

Draeget Medical AG & Co. KGaA, Telford PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041956 is the FDA 510(k) clearance record for EMG - ESSENTIAL GAS MODULE, MODEL M1013A, a class II device, cleared for Draeget Medical AG & Co. Kgaa on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 2 510(k) clearances for Draeget Medical AG & Co. Kgaa, from to . As of , FDA records show no recalls naming K041956.

Clearance record

Decision date
Received
(19 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Draeget Medical AG & Co. Kgaa 3135 Quarry Rd., Telford PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCK

Trailing 12 months
3 clearances under product code CCK in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260