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FDA 510(k)

SYSTEM 5000

K-Number: K833756 · 1984-04-24

ApplicantMedical Graphics Corp.
Decision Date1984-04-24
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corp.. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K833756. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 5000?

SYSTEM 5000 is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Medical Graphics Corp.. The 510(k) number is K833756.

When did SYSTEM 5000 receive FDA 510(k) clearance?

SYSTEM 5000 received FDA 510(k) clearance on 1984-04-24, under 510(k) number K833756.

Who is the listed applicant for SYSTEM 5000?

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

What is the FDA product code for SYSTEM 5000?

The FDA product code for SYSTEM 5000 is DXG.

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Other records listing Medical Graphics 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.

K152585Resmon PRO FULLK070858EXPRESS SERIESK061731MEDGRAPHICS ULTIMA SYSTEMK955432CPX, CCM, CATH WITH 15% CO2K9432591085 ULTIMATE E PLETHYSMOGRAPHK923209MEDGRAPHICS EXERCISE CONSULT

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Related Devices (Code: DXG)

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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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