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FDA 510(k)

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)

K-Number: K861013 · 1986-03-31

ApplicantAmeritek, Inc.
Decision Date1986-03-31
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K861013. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)?

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Ameritek, Inc.. The 510(k) number is K861013.

When did ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) receive FDA 510(k) clearance?

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) received FDA 510(k) clearance on 1986-03-31, under 510(k) number K861013.

Who is the listed applicant for ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)?

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

What is the FDA product code for ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)?

The FDA product code for ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) is KYG.

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

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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