STARLIGHT— 510(k) K133250

Substantially Equivalent

Orthomerica Products, Inc.

FDA 510(k) clearance K133250 for STARLIGHT, Substantially Equivalent on 2014-01-16. Applicant: Orthomerica Products, Inc.. Device class: 2.

Clearance details

Applicant: Orthomerica Products, Inc.
Product code: Code OAN
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2013-10-22
Decision date: 2014-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

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