MTC 6210A Cardiac Output Computer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K854371 FDA 510(k)
- FDA Product Code
- DXG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1435 FDA 510(k)
- Regulation Number
- 870.1435 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MTC 6210A Cardiac Output Computer is a diagnostic, pre-programmed, single-function computer device classified under product code DXG and regulation number 870.1435. It is designed for cardiovascular applications and was determined to be substantially equivalent through a traditional 510(k) clearance process.
The device received FDA 510(k) clearance under K854371 on February 19, 1987, following a submission received on October 29, 1985. It is manufactured by Nihon Kohden America, Inc. and is intended for use in clinical settings as a diagnostic tool for cardiac output measurement.
Frequently asked questions
What is the MTC 6210A Cardiac Output Computer used for?
The MTC 6210A Cardiac Output Computer is designed as a diagnostic tool for measuring cardiac output in clinical settings, specifically for cardiovascular applications, based on its classification under product code DXG and regulation number 870.1435.
How was the MTC 6210A Cardiac Output Computer cleared for market?
The device received FDA 510(k) clearance through a traditional process under submission K854371, which was received on October 29, 1985, and cleared on February 19, 1987, after being determined substantially equivalent to a predicate device.
Who manufactures the MTC 6210A Cardiac Output Computer and where is it located?
The MTC 6210A Cardiac Output Computer is manufactured by Nihon Kohden America, Inc., located at 17112 Armstrong Ave., Irvine, CA 92714, United States, as indicated in the device’s registration and applicant information.
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: K854371 FDA 510 (k) - MTC 6210A CARDIAC OUTPUT COMPUTER, MTC 6210A CARDIAC OUTPUT COMPUTER - Innolitics, Mtc 6210a Cardiac Output Computer - Beudamed, Mtc 6210a Cardiac Output Computer 510 (k) FDA Premarket Notification ..., PDF K854371 - Mtc 6210a Cardiac Output Computer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K854371 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden America, Inc.
Sources (1)
- FDA 510(k) K854371 24 fields · synced Oct 1, 2026