CARDIAC REVIEW STATION— 510(k) K812515

Substantially Equivalent

Diasonics, Inc.

FDA 510(k) clearance K812515 for CARDIAC REVIEW STATION, Substantially Equivalent on 1981-10-02. Applicant: Diasonics, Inc.. Device class: 2.

Clearance details

Applicant: Diasonics, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1981-09-02
Decision date: 1981-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.