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FDA 510(k)

UP800 A UNIVERSAL PRINTER

K-Number: K845050 · 1985-05-29

ApplicantMadsen Electronics (Canada) , Ltd.
Decision Date1985-05-29
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UP800 A UNIVERSAL PRINTER is the device name listed in this FDA 510(k) record. The listed applicant is Madsen Electronics (Canada) , Ltd.. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K845050. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UP800 A UNIVERSAL PRINTER?

UP800 A UNIVERSAL PRINTER is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Madsen Electronics (Canada) , Ltd.. The 510(k) number is K845050.

When did UP800 A UNIVERSAL PRINTER receive FDA 510(k) clearance?

UP800 A UNIVERSAL PRINTER received FDA 510(k) clearance on 1985-05-29, under 510(k) number K845050.

Who is the listed applicant for UP800 A UNIVERSAL PRINTER?

The FDA 510(k) record lists Madsen Electronics (Canada) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UP800 A UNIVERSAL PRINTER?

The FDA product code for UP800 A UNIVERSAL PRINTER is EWO.

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Other records listing Madsen Electronics (Canada) , Ltd. 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.

K942749HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENTK931325OTOACOUSTIC EMISSIONS UNIT CELESTA 503K931324ORBITER 922 CLINICAL AUDIOMETERK910247ZODIAC 901 MIDDLE-EAR ANALYZERK884372MADSEN IGO1500 INSERTION GAIN OPTIMIZERK884371MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM

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Related Devices (Code: EWO)

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.

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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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