THERATRON ELITE— 510(k) K983917

Substantially Equivalent

Theratronics, Inc.

FDA 510(k) clearance K983917 for THERATRON ELITE, Substantially Equivalent on 1998-12-04. Applicant: Theratronics, Inc.. Device class: 2.

Clearance details

Applicant: Theratronics, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1998-11-04
Decision date: 1998-12-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Kanata, Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Theratronics, Inc.

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