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FDA 510(k)

STRESS TEST SYSTEM

K-Number: K810357 · 1981-03-11

ApplicantNihon Kohden America, Inc.
Decision Date1981-03-11
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STRESS TEST SYSTEM 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 1981-03-11 under 510(k) number K810357. 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 STRESS TEST SYSTEM?

STRESS TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K810357.

When did STRESS TEST SYSTEM receive FDA 510(k) clearance?

STRESS TEST SYSTEM received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810357.

Who is the listed applicant for STRESS TEST SYSTEM?

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 STRESS TEST SYSTEM?

The FDA product code for STRESS TEST SYSTEM is DPS.

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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: DPS)

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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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