G.E. DXD 325/350/350II/DXD 525/525II GENERATORS— 510(k) K902986

Name: FDA 510(k) clearance K902986
Creator: U.S. Food and Drug Administration
Published: 1991-02-13

Substantially Equivalent

Electromek Diagnostic Systems, Inc.

FDA 510(k) clearance K902986 for G.E. DXD 325/350/350II/DXD 525/525II GENERATORS, Substantially Equivalent on 1991-02-13. Applicant: Electromek Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Electromek Diagnostic Systems, Inc.
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1990-06-26
Decision date: 1991-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, IL, US

Download summary PDF View on FDA.gov ↗

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K902987 — G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS1990-12-26
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K902988 — G.E. MSI 850/850II/1250 THREE PHASE GENERATORS1990-12-19
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Data sourced from openFDA. This site is unofficial and independent of the FDA.