DIOBEAM 830— 510(k) K031499

Substantially Equivalent

Soft-Core Texas, Inc.

FDA 510(k) clearance K031499 for DIOBEAM 830, Substantially Equivalent on 2003-09-16. Applicant: Soft-Core Texas, Inc.. Device class: 2.

Clearance details

Applicant: Soft-Core Texas, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2003-05-13
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Richland Hills, TX, 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.