FDA 510(k)

NIL

K-Number: K943613 · 1994-09-21

ApplicantSing Wah International Enterprises , Ltd.

Decision Date1994-09-21

Product CodeHOI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

NIL is the device name listed in this FDA 510(k) record. The listed applicant is Sing Wah International Enterprises , Ltd.. It received FDA 510(k) clearance on 1994-09-21 under 510(k) number K943613. The device is classified under product code HOI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIL?

NIL is a medical device that received FDA 510(k) clearance on 1994-09-21. The listed applicant is Sing Wah International Enterprises , Ltd.. The 510(k) number is K943613.

When did NIL receive FDA 510(k) clearance?

NIL received FDA 510(k) clearance on 1994-09-21, under 510(k) number K943613.

Who is the listed applicant for NIL?

The FDA 510(k) record lists Sing Wah International Enterprises , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIL?

The FDA product code for NIL is HOI.

Other records listing Sing Wah International Enterprises , Ltd. 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.

K943263NIL

Related Devices (Code: HOI)

K930435SPECTACLE FRAMESVenis DI A. Vendrame K931328PYRAMID SUNGLASSES/PYRAMID READING GLASSESPyramid K910329SUNGLASSESCutler & Gross Sloan Optical , Ltd.K854854SYSTEMS OF SIGHT LOW VISION EYEWAREInt'L Eye Care, Inc.K844716MAGNIFYING SPECTACLES W/PLASTIC LENSESGazelle Corp.K844038VISITEC MAGNIFYING SPECTACLESVisitec Co.

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.