NDR+/DIVA-D— 510(k) K053029

Substantially Equivalent

Nical Spa

FDA 510(k) clearance K053029 for NDR+/DIVA-D, Substantially Equivalent on 2006-01-06. Applicant: Nical Spa. Device class: 2.

Clearance details

Applicant: Nical Spa
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2005-10-27
Decision date: 2006-01-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hasting On Hudson, NY, 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.