FDA 510(k)

I.V. SKY-HOOK

K-Number: K912010 · 1991-08-19

ApplicantDina - Industria, Comercio E Exportacao , Ltd.

Decision Date1991-08-19

Product CodeFOX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

I.V. SKY-HOOK is the device name listed in this FDA 510(k) record. The listed applicant is Dina - Industria, Comercio E Exportacao , Ltd.. It received FDA 510(k) clearance on 1991-08-19 under 510(k) number K912010. The device is classified under product code FOX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V. SKY-HOOK?

I.V. SKY-HOOK is a medical device that received FDA 510(k) clearance on 1991-08-19. The listed applicant is Dina - Industria, Comercio E Exportacao , Ltd.. The 510(k) number is K912010.

When did I.V. SKY-HOOK receive FDA 510(k) clearance?

I.V. SKY-HOOK received FDA 510(k) clearance on 1991-08-19, under 510(k) number K912010.

Who is the listed applicant for I.V. SKY-HOOK?

The FDA 510(k) record lists Dina - Industria, Comercio E Exportacao , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. SKY-HOOK?

The FDA product code for I.V. SKY-HOOK is FOX.

Related Devices (Code: FOX)

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.

K980336IV STANDSClinton Industries, Inc.K964782MEDRAD CONTRAST HOLDERMedrad, Inc.K961470PORT-A-POLEPrins Medical Ind., Inc.K960027HIGH VOLUME I.V. & IRRIGATION TOWERAllen Medical Systems, Inc.K952196IV POLE/STANDValentine Intl. , Ltd.K950367IV SHUTTLEEquipment Concepts, Inc.

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.