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FDA 510(k)

MTC 6210A CARDIAC OUTPUT COMPUTER

K-Number: K854371 · 1987-02-19

ApplicantNihon Kohden America, Inc.
Decision Date1987-02-19
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MTC 6210A CARDIAC OUTPUT COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K854371. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTC 6210A CARDIAC OUTPUT COMPUTER?

MTC 6210A CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K854371.

When did MTC 6210A CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

MTC 6210A CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1987-02-19, under 510(k) number K854371.

Who is the listed applicant for MTC 6210A CARDIAC OUTPUT COMPUTER?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTC 6210A CARDIAC OUTPUT COMPUTER?

The FDA product code for MTC 6210A CARDIAC OUTPUT COMPUTER is DXG.

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Other records listing Nihon Kohden America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

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Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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