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FDA 510(k)

UNIVERSAL CONTROLLER, MODEL 100

K-Number: K934543 · 1994-03-29

ApplicantMetamed, Inc.
Decision Date1994-03-29
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL CONTROLLER, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Metamed, Inc.. It received FDA 510(k) clearance on 1994-03-29 under 510(k) number K934543. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL CONTROLLER, MODEL 100?

UNIVERSAL CONTROLLER, MODEL 100 is a medical device that received FDA 510(k) clearance on 1994-03-29. The listed applicant is Metamed, Inc.. The 510(k) number is K934543.

When did UNIVERSAL CONTROLLER, MODEL 100 receive FDA 510(k) clearance?

UNIVERSAL CONTROLLER, MODEL 100 received FDA 510(k) clearance on 1994-03-29, under 510(k) number K934543.

Who is the listed applicant for UNIVERSAL CONTROLLER, MODEL 100?

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

What is the FDA product code for UNIVERSAL CONTROLLER, MODEL 100?

The FDA product code for UNIVERSAL CONTROLLER, MODEL 100 is LDR.

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Related Devices (Code: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

Official Source

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

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