As/3(Tm) Anesthesia Monitor Syst Interface Board
by Datex Division Instrumentarium Corp.
510(k) K935477
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935477 | Date1 Aug 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- Withdrawn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
- 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, 23 Sep 2026
The AS/3 Anesthesia Monitor System Interface Board is a component of the AS/3 Anesthesia Monitor System, designed to interface with monitoring equipment in anesthesia settings. It serves as a connection point for various monitoring functions within the anesthesia system.
This device is supplied as a single-use or reusable component, depending on the specific application. It is manufactured by Datex Division Instrumentarium Corp. and has FDA 510K clearance with product code CCK. The device is intended for use in anesthesia monitoring systems and is available in various sizes as specified by the manufacturer.
Other devices from Datex Division Instrumentarium Corp.
Questions
AI-generated answers, 23 Sep 2026
What is the AS/3 Anesthesia Monitor System Interface Board used for?
The AS/3 Anesthesia Monitor System Interface Board is designed to interface with monitoring equipment in anesthesia settings, serving as a connection point for various monitoring functions within the anesthesia system.
Is the AS/3 Anesthesia Monitor System Interface Board single-use or reusable?
The device is supplied as either a single-use or reusable component, depending on the specific application requirements as specified by the manufacturer.
What regulatory approvals does the AS/3 Anesthesia Monitor System Interface Board have?
The device has FDA 510K clearance with product code CCK, indicating it has been determined to be substantially equivalent to existing devices in the market.
What sizes and models of the AS/3 Anesthesia Monitor System Interface Board are available?
The device is available in various sizes as specified by the manufacturer, though specific dimensions or model variations are not detailed in the provided information.