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FDA 510(k)

MLC-4200 CARDIAC OUTPUT COMPUTER

K-Number: K802305 · 1980-10-10

ApplicantNihon Kohden America, Inc.
Decision Date1980-10-10
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MLC-4200 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 1980-10-10 under 510(k) number K802305. 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 MLC-4200 CARDIAC OUTPUT COMPUTER?

MLC-4200 CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K802305.

When did MLC-4200 CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

MLC-4200 CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802305.

Who is the listed applicant for MLC-4200 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 MLC-4200 CARDIAC OUTPUT COMPUTER?

The FDA product code for MLC-4200 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.

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Related Devices (Code: DXG)

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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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