SPEC MODEL M-31— 510(k) K090366

Name: FDA 510(k) clearance K090366
Creator: U.S. Food and Drug Administration
Published: 2009-04-22

Substantially Equivalent

Source Production & Equipment Co., Inc.

FDA 510(k) clearance K090366 for SPEC MODEL M-31, Substantially Equivalent on 2009-04-22. Applicant: Source Production & Equipment Co., Inc.. Device class: 2.

Clearance details

Applicant: Source Production & Equipment Co., Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2009-02-13
Decision date: 2009-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Rose, LA, US

Download summary PDF View on FDA.gov ↗

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