PEDIATRIC POSITIONER PAD SET— 510(k) K122174

Name: FDA 510(k) clearance K122174
Creator: U.S. Food and Drug Administration
Published: 2012-11-16

Substantially Equivalent

Ge Healthcare Coils (Usa Instruments, Inc.)

FDA 510(k) clearance K122174 for PEDIATRIC POSITIONER PAD SET, Substantially Equivalent on 2012-11-16. Applicant: Ge Healthcare Coils (Usa Instruments, Inc.). Device class: 1.

Clearance details

Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
Product code: Code KXH
Device class: Class 1
Regulation: 21 CFR 892.1830
Advisory panel: Radiology
Date received: 2012-07-23
Decision date: 2012-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXH

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K953246 — OCTOROLL1995-09-29
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K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE1993-07-13
K884292 — STRETCHER TABLE1989-03-31

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