SWIFT 2.0, MODEL 132.001— 510(k) K031158

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K031158 for SWIFT 2.0, MODEL 132.001, Substantially Equivalent on 2003-08-07. Applicant: Nucletron Corp.. Device class: 2.

Clearance details

Applicant: Nucletron Corp.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2003-04-11
Decision date: 2003-08-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, 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.