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FDA 510(k)

GX-ELEVATOR

K-Number: K894188 · 1989-10-03

ApplicantGendex Corp.
Decision Date1989-10-03
Product CodeIZZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GX-ELEVATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1989-10-03 under 510(k) number K894188. The device is classified under product code IZZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GX-ELEVATOR?

GX-ELEVATOR is a medical device that received FDA 510(k) clearance on 1989-10-03. The listed applicant is Gendex Corp.. The 510(k) number is K894188.

When did GX-ELEVATOR receive FDA 510(k) clearance?

GX-ELEVATOR received FDA 510(k) clearance on 1989-10-03, under 510(k) number K894188.

Who is the listed applicant for GX-ELEVATOR?

The FDA 510(k) record lists Gendex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GX-ELEVATOR?

The FDA product code for GX-ELEVATOR is IZZ.

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Other records listing Gendex Corp. 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.

K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEMK945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK931001ORALIX DCK932675GXP DENTAL X-RAY PROCESSOR

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Related Devices (Code: IZZ)

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.

K971452MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLESiemens Medical Solutions USA, Inc.K952701MED-TRON SPECT IMAGING TABLEMed-Tron Products, Inc.K951315CATHETERIZATION TABLE KS-60Shimadzu Medical SystemsK951053ANGIOREX CAT-350BToshiba America Medical Systems, In.CK943926RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLEPhilips Medical Systems (Cleveland), Inc.K930273ALPHARaymax Medical Corp.

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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