RADKOR BS-10 AND BS-10T— 510(k) K891395

Substantially Equivalent

Radkor, Inc.

FDA 510(k) clearance K891395 for RADKOR BS-10 AND BS-10T, Substantially Equivalent on 1989-04-03. Applicant: Radkor, Inc.. Device class: 1.

Clearance details

Applicant: Radkor, Inc.
Product code: Code IXY
Device class: Class 1
Regulation: 21 CFR 892.1880
Advisory panel: Radiology
Date received: 1989-03-14
Decision date: 1989-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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