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FDA 510(k)

G.E. MONITROL 90 AND G.E. MONITROL 15

K-Number: K902989 · 1990-10-29

ApplicantElectromek Diagnostic Systems, Inc.
Decision Date1990-10-29
Product CodeIXR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

G.E. MONITROL 90 AND G.E. MONITROL 15 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 1990-10-29 under 510(k) number K902989. The device is classified under product code IXR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.E. MONITROL 90 AND G.E. MONITROL 15?

G.E. MONITROL 90 AND G.E. MONITROL 15 is a medical device that received FDA 510(k) clearance on 1990-10-29. The listed applicant is Electromek Diagnostic Systems, Inc.. The 510(k) number is K902989.

When did G.E. MONITROL 90 AND G.E. MONITROL 15 receive FDA 510(k) clearance?

G.E. MONITROL 90 AND G.E. MONITROL 15 received FDA 510(k) clearance on 1990-10-29, under 510(k) number K902989.

Who is the listed applicant for G.E. MONITROL 90 AND G.E. MONITROL 15?

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. MONITROL 90 AND G.E. MONITROL 15?

The FDA product code for G.E. MONITROL 90 AND G.E. MONITROL 15 is IXR.

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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.

K902986G.E. DXD 325/350/350II/DXD 525/525II GENERATORSK902987G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORSK902988G.E. MSI 850/850II/1250 THREE PHASE GENERATORSK902985G.E. MST 625/625II/MST 1050/1050II THREE PHASE GENK902982G.E. POLARIX II C-ARMK902981G.E. FLUOROCON 300 IMAGING SYSTEM

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Related Devices (Code: IXR)

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.

K000412VISION R/F TILTING TABLEVilla Sistemi Medicali S.P.A.K973039LEGACY/LEGACY-D TABLEGE Medical SystemsK971128CAP-35B III/CINE 275Jamieson Film Co.K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, 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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