SPECBOARD JR.— 510(k) K123414

Substantially Equivalent

Macbrud Corp., Medical Division

FDA 510(k) clearance K123414 for SPECBOARD JR., Substantially Equivalent on 2013-01-11. Applicant: Macbrud Corp., Medical Division. Device class: 2.

Clearance details

Applicant: Macbrud Corp., Medical Division
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2012-11-06
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.