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FDA 510(k)

ILLUMINATED SPECULUM

K-Number: K801058 · 1980-05-28

ApplicantDesigns For Vision, Inc.
Decision Date1980-05-28
Product CodeFXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ILLUMINATED SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Designs For Vision, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801058. The device is classified under product code FXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILLUMINATED SPECULUM?

ILLUMINATED SPECULUM is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Designs For Vision, Inc.. The 510(k) number is K801058.

When did ILLUMINATED SPECULUM receive FDA 510(k) clearance?

ILLUMINATED SPECULUM received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801058.

Who is the listed applicant for ILLUMINATED SPECULUM?

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

What is the FDA product code for ILLUMINATED SPECULUM?

The FDA product code for ILLUMINATED SPECULUM is FXF.

Related Clinical Trials

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Other records listing Designs For Vision, 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.

K051786MELIDE FIBEROPTIC LIGHTK043530DVI CURING LIGHTK032283DESIGNS FOR VISION FIBEROPTIC LIGHTK013880DAYLITE XENON LIGHT SOURCES

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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