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FDA 510(k)

CARDIAC REVIEW STATION

K-Number: K812515 · 1981-10-02

ApplicantDiasonics, Inc.
Decision Date1981-10-02
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC REVIEW STATION is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812515. 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 CARDIAC REVIEW STATION?

CARDIAC REVIEW STATION is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Diasonics, Inc.. The 510(k) number is K812515.

When did CARDIAC REVIEW STATION receive FDA 510(k) clearance?

CARDIAC REVIEW STATION received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812515.

Who is the listed applicant for CARDIAC REVIEW STATION?

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

What is the FDA product code for CARDIAC REVIEW STATION?

The FDA product code for CARDIAC REVIEW STATION is 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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