KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM— 510(k) K875334

Name: FDA 510(k) clearance K875334
Creator: U.S. Food and Drug Administration
Published: 1988-03-24

Substantially Equivalent

Kontron Instruments, Inc.

FDA 510(k) clearance K875334 for KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM, Substantially Equivalent on 1988-03-24. Applicant: Kontron Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Kontron Instruments, Inc.
Product code: Code HGL
Device class: Class 2
Regulation: 21 CFR 884.2960
Advisory panel: Obstetrics/Gynecology
Date received: 1987-12-30
Decision date: 1988-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Everett, MA, US

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