PANORAMIC X-RAY UNITS, MODIFICATION— 510(k) K934063

Name: FDA 510(k) clearance K934063
Creator: U.S. Food and Drug Administration
Published: 1993-12-15

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K934063 for PANORAMIC X-RAY UNITS, MODIFICATION, Substantially Equivalent on 1993-12-15. Applicant: Planmeca Oy. Device class: 2.

Clearance details

Applicant: Planmeca Oy
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1993-08-31
Decision date: 1993-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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