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FDA 510(k)

OPTI-SHIELD

K-Number: K924089 · 1993-03-31

ApplicantFuji Optical Systems, Inc.
Decision Date1993-03-31
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTI-SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Optical Systems, Inc.. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K924089. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-SHIELD?

OPTI-SHIELD is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Fuji Optical Systems, Inc.. The 510(k) number is K924089.

When did OPTI-SHIELD receive FDA 510(k) clearance?

OPTI-SHIELD received FDA 510(k) clearance on 1993-03-31, under 510(k) number K924089.

Who is the listed applicant for OPTI-SHIELD?

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

What is the FDA product code for OPTI-SHIELD?

The FDA product code for OPTI-SHIELD is EFB.

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Related Devices (Code: EFB)

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.

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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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