Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELECTRIC I/V POLE OR EIVP2

K-Number: K935003 · 1994-01-25

ApplicantOptical Micro Systems, Inc.
Decision Date1994-01-25
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ELECTRIC I/V POLE OR EIVP2 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 1994-01-25 under 510(k) number K935003. 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 ELECTRIC I/V POLE OR EIVP2?

ELECTRIC I/V POLE OR EIVP2 is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K935003.

When did ELECTRIC I/V POLE OR EIVP2 receive FDA 510(k) clearance?

ELECTRIC I/V POLE OR EIVP2 received FDA 510(k) clearance on 1994-01-25, under 510(k) number K935003.

Who is the listed applicant for ELECTRIC I/V POLE OR EIVP2?

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 ELECTRIC I/V POLE OR EIVP2?

The FDA product code for ELECTRIC I/V POLE OR EIVP2 is KYG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK935226I/V POLEK870068ASPIRATION REVERSAL CONTROL (ARC) MODULEK844373O.M.S. ULTRA-PHACO

View all 21 devices →

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.

↑