MTC 6210A Cardiac Output Computer
FDA 510(k) K854371 · Nihon Kohden America, Inc.
510(k) numberK854371
Submission
- Device name
- MTC 6210A Cardiac Output Computer
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- October 29, 1985
- Decision date
- February 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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Questions and answers
When was MTC 6210A Cardiac Output Computer cleared by the FDA?
MTC 6210A Cardiac Output Computer (K854371) received a 510(k) decision of Substantially Equivalent on February 19, 1987, 478 days after the submission was received.
What is the product code of K854371?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.