Datex AS/3 Anesthesia Monitor
by Datex Division Instrumentarium Corp.
510(k) K933285
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933285 | Date14 Nov 1994 | 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- Withdrawn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
- Full name
- Datex As/3 Tm Anaesthesia Monitor
- 510(k) Number
- FDA Product Code
- BSZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5160
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Datex AS/3 Anesthesia Monitor is a medical device classified as an Anesthesia Gas Machine, designed to monitor and manage patient anesthesia during surgical procedures. It provides real-time monitoring of vital parameters such as respiratory gases (e.g., oxygen, carbon dioxide, and anesthetic agents), capnography, pulse oximetry, and electrocardiogram (ECG) waveforms to ensure patient safety and optimal anesthetic delivery.
This device is intended for use in operating rooms, recovery areas, and critical care settings where anesthesia is administered. Supplied as a reusable medical instrument, it requires proper calibration, maintenance, and adherence to manufacturer guidelines for sterilization or disinfection. The Datex AS/3 Anesthesia Monitor complies with FDA 510(k) clearance under K-number K933285, classified under BSZ product code, and adheres to regulatory standards for anesthesia monitoring equipment, including those outlined in 21 CFR 868.5160.
Other devices from Datex Division Instrumentarium Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Datex AS/3 Anesthesia Monitor used for?
The Datex AS/3 Anesthesia Monitor is designed to monitor and manage patient anesthesia during surgical procedures. It continuously tracks vital parameters such as respiratory gases (oxygen, carbon dioxide, and anesthetic agents), capnography, pulse oximetry, and ECG waveforms. This ensures real-time patient safety and optimal anesthetic delivery in operating rooms, recovery areas, and critical care settings.
Is the Datex AS/3 Anesthesia Monitor reusable or single-use?
The Datex AS/3 Anesthesia Monitor is a reusable medical device. It requires proper calibration, maintenance, and adherence to manufacturer guidelines for sterilization or disinfection between uses to ensure safety and functionality.
What regulatory approval does the Datex AS/3 Anesthesia Monitor hold?
The Datex AS/3 Anesthesia Monitor holds FDA 510(k) clearance under the K-number K933285. It is classified under the BSZ product code and adheres to regulatory standards outlined in 21 CFR 868.5160, ensuring compliance with anesthesia monitoring equipment requirements.
How should the Datex AS/3 Anesthesia Monitor be stored?
While the provided data does not specify storage conditions, reusable medical devices like the Datex AS/3 Anesthesia Monitor should generally be stored in a clean, dry environment protected from extreme temperatures, direct sunlight, and physical damage. Follow the manufacturer’s guidelines for proper storage to maintain device integrity and functionality.
What types of settings is the Datex AS/3 Anesthesia Monitor intended for?
The Datex AS/3 Anesthesia Monitor is intended for use in clinical settings where anesthesia is administered, including operating rooms, recovery areas, and critical care units. Its comprehensive monitoring capabilities make it suitable for environments requiring precise control and real-time assessment of patient vital signs during surgical and anesthetic procedures.