EMG Essential Gas Module, Model M1013A
by Draeget Medical AG & Co. Kgaa
510(k) K041956
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041956 | Date9 Aug 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The EMG Essential Gas Module, Model M1013A, is an Analyzer, Gas, Carbon-dioxide, Gaseous-phase device designed for monitoring essential respiratory gases in clinical settings. It measures and displays concentrations of carbon dioxide and other gaseous-phase analytes to support patient ventilation and anesthesia management during surgical and critical care procedures.
This device is intended for use in anesthesiology environments and is supplied as a reusable component integrated into anesthesia workstations. It requires compliance with regulatory standards, including FDA clearance under 510(k) number K041956, and is classified under product code CCK. No specific sterility or single-use designation is stated in the data, though proper maintenance and calibration are implied for accurate performance.
Other devices from Draeget Medical AG & Co. Kgaa
Questions
AI-generated answers, 19 Sep 2026
Is the EMG Essential Gas Module, Model M1013A, designed for single-use or can it be reused in clinical settings?
The EMG Essential Gas Module, Model M1013A, is intended for reuse as part of an anesthesia workstation. Since it is described as a reusable component and no sterility or single-use designation is explicitly stated, proper maintenance, cleaning, and calibration are required to ensure accurate performance and compliance with clinical standards. Always follow manufacturer guidelines for reprocessing.
What types of gases does this device measure, and where is it primarily used?
The EMG Essential Gas Module, Model M1013A, is specifically designed to measure and display concentrations of carbon dioxide and other gaseous-phase analytes in the respiratory phase. It is intended for use in anesthesiology environments, particularly during surgical and critical care procedures where patient ventilation and anesthesia management are critical. The device supports real-time monitoring to ensure safe and effective respiratory support.
How is this device supplied, and what kind of anesthesia workstations does it integrate with?
The EMG Essential Gas Module, Model M1013A, is supplied as a reusable component that is integrated into anesthesia workstations. It is not sold as a standalone device but rather as part of a larger system used in clinical settings for monitoring respiratory gases during anesthesia. The integration ensures compatibility with existing anesthesia infrastructure for seamless operation.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The EMG Essential Gas Module, Model M1013A, received FDA clearance under 510(k) number K041956 through a Special 510(k) pathway, with a decision classification of Substantially Equivalent (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in anesthesiology environments. The clearance was reviewed by the Anesthesiology (AN) Advisory Committee.
Does this device require any special handling or storage conditions to maintain accuracy?
While the specifications do not explicitly detail storage conditions, as a reusable medical device used in anesthesia workstations, the EMG Essential Gas Module, Model M1013A, should be stored in a clean, dry environment to prevent contamination or damage. Proper maintenance, including regular calibration, is implied to ensure accurate measurement of carbon dioxide and other gaseous analytes. Always adhere to the manufacturer’s instructions for optimal performance and longevity.