A8, A9 Anesthesia System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201957 FDA 510(k)
- FDA Product Code
- BSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5160 FDA 510(k)
- Regulation Number
- 868.5160 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The A8, A9 Anesthesia System is a Gas-Machine, Anesthesia, designed for the precise delivery of anesthetic gases and vapors during surgical procedures. It integrates ventilation, monitoring, and gas blending capabilities to support controlled anesthesia administration in clinical settings, ensuring patient safety and procedural efficacy.
This system is supplied as a reusable medical device, intended for use in operating rooms and anesthesia care areas. It adheres to FDA 510(k) clearance and MDD regulatory standards, with a classification as a Class II device under 21 CFR 868.5160. The system is non-MRI compatible and requires proper calibration, maintenance, and storage per manufacturer guidelines to maintain performance and sterility.
Frequently asked questions
Is the A8, A9 Anesthesia System designed for single-use or can it be reused in multiple procedures?
The A8, A9 Anesthesia System is explicitly labeled as a reusable medical device. Since it is intended for use in operating rooms and anesthesia care areas, proper calibration, maintenance, and storage per manufacturer guidelines are required to ensure performance and sterility between uses. Reuse is only permitted if following the manufacturer’s instructions to maintain safety and functionality.
What regulatory pathways has the A8, A9 Anesthesia System undergone, and what does that mean for its use in clinical settings?
The system has received FDA 510(k) clearance and adheres to MDD (Medical Device Directive) regulatory standards, classifying it as a Class II device under 21 CFR 868.5160. This means it has undergone rigorous review by the FDA’s Anesthesiology Advisory Committee (AN) to ensure safety and effectiveness for delivering anesthetic gases and ventilation in surgical settings. The clearance confirms it meets U.S. standards for precision, reliability, and patient safety.
Does the A8, A9 Anesthesia System include ventilation capabilities, and if so, how does that integrate with anesthesia delivery?
Yes, the A8, A9 Anesthesia System integrates ventilation alongside its core functions of delivering anesthetic gases and vapors. This dual capability allows for controlled ventilation during procedures, ensuring synchronized delivery of anesthesia and respiratory support. The system is designed to enhance procedural efficacy and patient safety by combining these critical functions in a single unit.
What storage and maintenance requirements must be followed to keep the A8, A9 Anesthesia System functional and sterile?
The system requires proper calibration, maintenance, and storage as outlined by the manufacturer to preserve performance and sterility. Since it is reusable, it must be cleaned, disinfected, and stored in a controlled environment to prevent contamination or degradation. Adhering to these guidelines is essential to ensure accurate gas delivery, ventilation functionality, and compliance with clinical safety standards.
Are there multiple models or sizes available for the A8, A9 Anesthesia System, and how would a buyer determine the right fit for their facility?
The system is listed under multiple FEI (Facility Establishment Identifier) numbers, indicating variations in models or configurations (e.g., 3013188547, 3005783425, etc.). While exact specifications like size or feature differences aren’t detailed here, buyers should consult the manufacturer’s documentation or support team to select the model best suited to their facility’s workflow, patient volume, and specific anesthesia requirements. These variations may address differences in ventilation capacity, gas blending options, or integration with existing hospital systems.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201957 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K201957 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026