FDA 510(k)

SIOM

K-Number: K854343 · 1985-11-12

Decision Date1985-11-12

Product CodeHQZ

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SIOM 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 1985-11-12 under 510(k) number K854343. 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 SIOM?

SIOM is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is South West Intl., Inc.. The 510(k) number is K854343.

When did SIOM receive FDA 510(k) clearance?

SIOM received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854343.

Who is the listed applicant for SIOM?

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 SIOM?

The FDA product code for SIOM is HQZ.

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.

K862503KOELN OPTIK K862502MASUNAGA OPTICAL MANUFACTURING K851661SOLEX & SAXON INT'L OPTICAL OF HONG KONG

Related Devices (Code: HQZ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.