IMATION SE-204 LASER IMAGER— 510(k) K972822

Name: FDA 510(k) clearance K972822
Creator: U.S. Food and Drug Administration
Published: 1997-11-19

Substantially Equivalent

Imation Enterprises Corp.

FDA 510(k) clearance K972822 for IMATION SE-204 LASER IMAGER, Substantially Equivalent on 1997-11-19. Applicant: Imation Enterprises Corp.. Device class: 2.

Clearance details

Applicant: Imation Enterprises Corp.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 1997-07-30
Decision date: 1997-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.