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FDA 510(k)

KOELN OPTIK

K-Number: K862503 · 1986-07-11

ApplicantSouth West Intl., Inc.
Decision Date1986-07-11
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOELN OPTIK is the device name listed in this FDA 510(k) record. The listed applicant is South West Intl., Inc.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862503. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOELN OPTIK?

KOELN OPTIK is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is South West Intl., Inc.. The 510(k) number is K862503.

When did KOELN OPTIK receive FDA 510(k) clearance?

KOELN OPTIK received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862503.

Who is the listed applicant for KOELN OPTIK?

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

What is the FDA product code for KOELN OPTIK?

The FDA product code for KOELN OPTIK is HQZ.

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 South West Intl., 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.

K862502MASUNAGA OPTICAL MANUFACTURINGK854343SIOMK851661SOLEX & SAXON INT'L OPTICAL OF HONG KONG

Related Devices (Code: HQZ)

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.

K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.K945770OPTICAL FRAMESRamada Optics, Inc.K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., 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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