Kion Anaesthesia System, Model 65 03 879 E392E
510(k) K010923
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010923 | Date23 Jan 2002 | 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- Withdrawn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
- MHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Kion Anaesthesia System, Model 65 03 879 E392e, is a medical device classified as a Monitor, Physiological, Patient, with arrhythmia detection or alarms. It is a class 2 medical device. The device is used in the cardiovascular medical specialty.
The device is supplied by Siemens Elema AB and has been cleared by the FDA with a 510(k) number of K010923. The clearance type is abbreviated and the regulation number is 870.1025. The device was found to be substantially equivalent and was cleared on January 23, 2002.
Other devices from Siemens Elema AB
Questions
AI-generated answers, 22 Sep 2026
What is the Kion Anaesthesia System used for?
The Kion Anaesthesia System is used in the cardiovascular medical specialty for monitoring patients with arrhythmia detection or alarms.
Is the Kion Anaesthesia System a single-use device?
The device data does not specify if the Kion Anaesthesia System is for single-use or reuse, but it is classified as a class 2 medical device.
What is the regulatory status of the Kion Anaesthesia System?
The Kion Anaesthesia System has been cleared by the FDA with a 510(k) number of K010923, and is regulated under 870.1025.
Who manufactures the Kion Anaesthesia System?
The Kion Anaesthesia System is manufactured by Siemens Elema AB.