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FDA 510(k)

VARI-SET

K-Number: K894111 · 1989-09-28

ApplicantSonex Medical
Decision Date1989-09-28
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VARI-SET is the device name listed in this FDA 510(k) record. The listed applicant is Sonex Medical. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894111. 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 VARI-SET?

VARI-SET is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Sonex Medical. The 510(k) number is K894111.

When did VARI-SET receive FDA 510(k) clearance?

VARI-SET received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894111.

Who is the listed applicant for VARI-SET?

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

What is the FDA product code for VARI-SET?

The FDA product code for VARI-SET is LDR.

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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