THERATON 1000E— 510(k) K964607

Substantially Equivalent

Theratronics, Inc.

FDA 510(k) clearance K964607 for THERATON 1000E, Substantially Equivalent on 1997-05-28. Applicant: Theratronics, Inc.. Device class: 2.

Clearance details

Applicant: Theratronics, Inc.
Product code: Code IWD
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1996-11-18
Decision date: 1997-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

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K954679 — THERAPLAN PLUS1996-11-08
K940237 — THERAPLAN V05B/ TP-11 V09B1994-07-26

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