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FDA 510(k)

ELECTROCARDIOGRAPH INTERPRETER

K-Number: K822968 · 1982-12-15

ApplicantSuzuken Co., Ltd.
Decision Date1982-12-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH INTERPRETER is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K822968. 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 ELECTROCARDIOGRAPH INTERPRETER?

ELECTROCARDIOGRAPH INTERPRETER is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K822968.

When did ELECTROCARDIOGRAPH INTERPRETER receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH INTERPRETER received FDA 510(k) clearance on 1982-12-15, under 510(k) number K822968.

Who is the listed applicant for ELECTROCARDIOGRAPH INTERPRETER?

The FDA 510(k) record lists Suzuken Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROCARDIOGRAPH INTERPRETER?

The FDA product code for ELECTROCARDIOGRAPH INTERPRETER is DSI.

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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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