SPEC MODEL M15— 510(k) K132969

Name: FDA 510(k) clearance K132969
Creator: U.S. Food and Drug Administration
Published: 2014-01-02

Substantially Equivalent

Source Production & Equipment Co., Inc.

FDA 510(k) clearance K132969 for SPEC MODEL M15, Substantially Equivalent on 2014-01-02. 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: 2013-09-23
Decision date: 2014-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Rose, LA, US

Download summary PDF View on FDA.gov ↗

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