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FDA 510(k)

G.E. DXD 325/350/350II/DXD 525/525II GENERATORS

K-Number: K902986 · 1991-02-13

ApplicantElectromek Diagnostic Systems, Inc.
Decision Date1991-02-13
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

G.E. DXD 325/350/350II/DXD 525/525II GENERATORS is the device name listed in this FDA 510(k) record. The listed applicant is Electromek Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-02-13 under 510(k) number K902986. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.E. DXD 325/350/350II/DXD 525/525II GENERATORS?

G.E. DXD 325/350/350II/DXD 525/525II GENERATORS is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Electromek Diagnostic Systems, Inc.. The 510(k) number is K902986.

When did G.E. DXD 325/350/350II/DXD 525/525II GENERATORS receive FDA 510(k) clearance?

G.E. DXD 325/350/350II/DXD 525/525II GENERATORS received FDA 510(k) clearance on 1991-02-13, under 510(k) number K902986.

Who is the listed applicant for G.E. DXD 325/350/350II/DXD 525/525II GENERATORS?

The FDA 510(k) record lists Electromek Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G.E. DXD 325/350/350II/DXD 525/525II GENERATORS?

The FDA product code for G.E. DXD 325/350/350II/DXD 525/525II GENERATORS is IZO.

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Other records listing Electromek Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K902987G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORSK902985G.E. MST 625/625II/MST 1050/1050II THREE PHASE GENK902988G.E. MSI 850/850II/1250 THREE PHASE GENERATORSK902982G.E. POLARIX II C-ARMK902981G.E. FLUOROCON 300 IMAGING SYSTEMK902983SIEMEN'S SIREMOBILE II C-ARM

View all 11 devices →

Related Devices (Code: IZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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