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FDA 510(k)

OPTIMED ADVANTAGE

K-Number: K883458 · 1988-11-07

ApplicantOptimed, Inc.
Decision Date1988-11-07
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIMED ADVANTAGE is the device name listed in this FDA 510(k) record. The listed applicant is Optimed, Inc.. It received FDA 510(k) clearance on 1988-11-07 under 510(k) number K883458. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMED ADVANTAGE?

OPTIMED ADVANTAGE is a medical device that received FDA 510(k) clearance on 1988-11-07. The listed applicant is Optimed, Inc.. The 510(k) number is K883458.

When did OPTIMED ADVANTAGE receive FDA 510(k) clearance?

OPTIMED ADVANTAGE received FDA 510(k) clearance on 1988-11-07, under 510(k) number K883458.

Who is the listed applicant for OPTIMED ADVANTAGE?

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

What is the FDA product code for OPTIMED ADVANTAGE?

The FDA product code for OPTIMED ADVANTAGE is HPT.

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 Optimed, 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.

K903462OPTIMED GLAUCOMA PRESSURE REGULATORK890687ECT-100 ELECTRONIC CORNEAL TOPOGRAPHERK884867OPTIFIELD I AND II AUTOMATED PERIMETERS

Related Devices (Code: HPT)

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.

K092187MAIA, MODEL 1Centervue S.P.A.K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.K091579FORESEE HOMENotal Vision , Ltd.K063310TRUEFIELD ANALYZERSeeing Machines LimitedK050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.K023623NOVAVISION, MODEL 2.0Novavision, 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.

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