X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS— 510(k) K901997

Name: FDA 510(k) clearance K901997
Creator: U.S. Food and Drug Administration
Published: 1990-06-06

Substantially Equivalent

Comet Ltd. C/O Radiology Resources, Inc.

FDA 510(k) clearance K901997 for X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS, Substantially Equivalent on 1990-06-06. Applicant: Comet Ltd. C/O Radiology Resources, Inc.. Device class: 2.

Clearance details

Applicant: Comet Ltd. C/O Radiology Resources, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1990-05-02
Decision date: 1990-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Switzerland, CH

Download summary PDF View on FDA.gov ↗

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