SINVISION LINEAR ARRAY REAL TIME— 510(k) K800653

Name: FDA 510(k) clearance K800653
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Kt Medical, Inc.

FDA 510(k) clearance K800653 for SINVISION LINEAR ARRAY REAL TIME, Substantially Equivalent on 1980-07-21. Applicant: Kt Medical, Inc.. Device class: 2.

Clearance details

Applicant: Kt Medical, Inc.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1980-03-24
Decision date: 1980-07-21
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.