AS/3 Anesthesia Monitor With S-ANE99(A)/L-ARK99(A)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K000815 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AS/3 Anesthesia Monitor is a physiological patient monitor with arrhythmia detection and alarms. It is designed to monitor an electrocardiogram and produce visible or audible signals when detecting atrial or ventricular arrhythmias. The device is classified as a Monitor, Physiological, Patient (with Arrhythmia Detection Or Alarms).
The AS/3 Anesthesia Monitor is manufactured by Datex-Ohmeda Inc. and received FDA 510(k) clearance on June 8, 2000, as substantially equivalent. It is a Class II device under product code MHX with special controls. The device is supplied with model numbers S-ANE99(A) and L-ARK99(A), and is regulated under 870.1025.
Frequently asked questions
What is the AS/3 Anesthesia Monitor used for?
The AS/3 Anesthesia Monitor is a physiological patient monitor designed to track electrocardiogram readings and detect atrial or ventricular arrhythmias, providing visible or audible alerts when irregularities are identified.
How is the AS/3 Anesthesia Monitor supplied?
The device is supplied with model numbers S-ANE99(A) and L-ARK99(A), manufactured by Datex-Ohmeda Inc. It is designed for clinical environments requiring continuous patient monitoring during anesthesia procedures.
What is the regulatory status of the AS/3 Anesthesia Monitor?
The AS/3 Anesthesia Monitor received FDA 510(k) clearance on June 8, 2000, as substantially equivalent. It is classified as a Class II device under product code MHX with special controls, regulated under 870.1025.
What features does the AS/3 Anesthesia Monitor offer?
The monitor provides comprehensive ECG monitoring with specialized arrhythmia detection capabilities. It is designed to produce visible or audible signals when detecting atrial or ventricular arrhythmias, assisting clinicians in patient assessment during anesthesia procedures.
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. Sources consulted: AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)… - FDA.report, K000815 - As/3 Anesthesia Montior With S-ane99 (A)..., AS/3 ANESTHESIA MONTIOR WITH S-ANE99 (A)/L-ARK99 (A) by DATEX-OHMEDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K000815 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda
Sources (1)
- FDA 510(k) K000815 24 fields · synced Sep 27, 2026