DIOLASE— 510(k) K904753

Substantially Equivalent

Scanditronix, Inc.

FDA 510(k) clearance K904753 for DIOLASE, Substantially Equivalent on 1990-11-09. Applicant: Scanditronix, Inc.. Device class: 1.

Clearance details

Applicant: Scanditronix, Inc.
Product code: Code IWE
Device class: Class 1
Regulation: 21 CFR 892.5780
Advisory panel: Radiology
Date received: 1990-10-19
Decision date: 1990-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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