POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM— 510(k) K911275

Name: FDA 510(k) clearance K911275
Creator: U.S. Food and Drug Administration
Published: 1991-05-09

Substantially Equivalent

Positron

FDA 510(k) clearance K911275 for POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM, Substantially Equivalent on 1991-05-09. Applicant: Positron. Device class: 2.

Clearance details

Applicant: Positron
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1991-03-22
Decision date: 1991-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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