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FDA 510(k)

I/V POLE

K-Number: K935226 · 1994-02-16

ApplicantOptical Micro Systems, Inc.
Decision Date1994-02-16
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

I/V POLE is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1994-02-16 under 510(k) number K935226. 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 I/V POLE?

I/V POLE is a medical device that received FDA 510(k) clearance on 1994-02-16. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K935226.

When did I/V POLE receive FDA 510(k) clearance?

I/V POLE received FDA 510(k) clearance on 1994-02-16, under 510(k) number K935226.

Who is the listed applicant for I/V POLE?

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

What is the FDA product code for I/V POLE?

The FDA product code for I/V POLE is KYG.

Other records listing Optical Micro Systems, Inc. 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.

K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULEK844373O.M.S. ULTRA-PHACO

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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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