EZSENSOR P DIGITAL INTRAORAL SENSOR— 510(k) K121132

Name: FDA 510(k) clearance K121132
Creator: U.S. Food and Drug Administration
Published: 2012-05-10

Substantially Equivalent

Humanray Co,Ltd

FDA 510(k) clearance K121132 for EZSENSOR P DIGITAL INTRAORAL SENSOR, Substantially Equivalent on 2012-05-10. Applicant: Humanray Co,Ltd. Device class: 2.

Clearance details

Applicant: Humanray Co,Ltd
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2012-04-13
Decision date: 2012-05-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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