Cardiovit AT-10PLUS
FDA 510(k)Class II (US FDA 510(k))
by Schiller AG
Identifiers
- 510(k) Number
- K050686 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cardiovit AT-10Plus is an ECG machine manufactured by Schiller AG. It is designed for high-volume ECG environments and can be used wherever ECG and spirometry data must meet highest demands.
The device is supplied by Schiller AG and has FDA 510K clearance with product code DPS. It is used in clinics and practices, including in high-demand environments such as the international space station ISS and its control centers.
Frequently asked questions
What is the Cardiovit AT-10Plus used for?
The Cardiovit AT-10Plus is an ECG machine designed for high-volume ECG environments where ECG and spirometry data must meet highest demands. It is used in clinics, practices, and demanding settings including the international space station ISS and its control centers.
What regulatory approvals does the Cardiovit AT-10Plus have?
The Cardiovit AT-10Plus has FDA 510K clearance with product code DPS. It was received by the FDA on 2005-03-16 and granted clearance on 2005-05-04 with a decision code of SESE, indicating it is substantially equivalent to other devices.
How is the Cardiovit AT-10Plus supplied?
The Cardiovit AT-10Plus is supplied by Schiller AG, which is located at Altgasse 68, CH-6341 Baar, Switzerland. The contact person for this device is Markus Büetler.
What advisory committee reviewed the Cardiovit AT-10Plus?
The Cardiovit AT-10Plus was reviewed by the Cardiovascular (CV) advisory committee, which specializes in cardiovascular devices. This indicates the device's focus on cardiovascular diagnostic capabilities.
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: Schiller CARDIOVIT AT-10Plus ECG Machine, PDF CARDIOVIT AT-10 plus, Schiller - CARDIOVIT AT-10 plus - medwrench.com, Schiller Cardiovit AT-10 Plus Stress System - Lifeline Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050686 | Class II | Active |
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Manufacturer
- Manufacturer
- Schiller AG
Sources (1)
- FDA 510(k) K050686 24 fields · synced Sep 28, 2026