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FDA 510(k)

CARDIOFAX CE, MODEL PEA-1110K

K-Number: K042827 · 2005-01-06

ApplicantNihon Kohden America, Inc.
Decision Date2005-01-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOFAX CE, MODEL PEA-1110K 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 2005-01-06 under 510(k) number K042827. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOFAX CE, MODEL PEA-1110K?

CARDIOFAX CE, MODEL PEA-1110K is a medical device that received FDA 510(k) clearance on 2005-01-06. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K042827.

When did CARDIOFAX CE, MODEL PEA-1110K receive FDA 510(k) clearance?

CARDIOFAX CE, MODEL PEA-1110K received FDA 510(k) clearance on 2005-01-06, under 510(k) number K042827.

Who is the listed applicant for CARDIOFAX CE, MODEL PEA-1110K?

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 CE, MODEL PEA-1110K?

The FDA product code for CARDIOFAX CE, MODEL PEA-1110K is DPS.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: DPS)

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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