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FDA 510(k)

CARDIOFAX-V ECG-834OA

K-Number: K865032 · 1987-03-10

ApplicantNihon Kohden America, Inc.
Decision Date1987-03-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOFAX-V ECG-834OA 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 1987-03-10 under 510(k) number K865032. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOFAX-V ECG-834OA?

CARDIOFAX-V ECG-834OA is a medical device that received FDA 510(k) clearance on 1987-03-10. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K865032.

When did CARDIOFAX-V ECG-834OA receive FDA 510(k) clearance?

CARDIOFAX-V ECG-834OA received FDA 510(k) clearance on 1987-03-10, under 510(k) number K865032.

Who is the listed applicant for CARDIOFAX-V ECG-834OA?

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 CARDIOFAX-V ECG-834OA?

The FDA product code for CARDIOFAX-V ECG-834OA is DSI.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: DSI)

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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