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FDA 510(k)

VELSCOPE

K-Number: K060920 · 2006-04-27

ApplicantLed Medical Diagnostics, Inc.
Decision Date2006-04-27
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VELSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Led Medical Diagnostics, Inc.. It received FDA 510(k) clearance on 2006-04-27 under 510(k) number K060920. The device is classified under product code NXV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELSCOPE?

VELSCOPE is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Led Medical Diagnostics, Inc.. The 510(k) number is K060920.

When did VELSCOPE receive FDA 510(k) clearance?

VELSCOPE received FDA 510(k) clearance on 2006-04-27, under 510(k) number K060920.

Who is the listed applicant for VELSCOPE?

The FDA 510(k) record lists Led Medical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELSCOPE?

The FDA product code for VELSCOPE is NXV.

Related Clinical Trials

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Related Devices (Code: NXV)

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.

K123169ORALIDForward Science, LLCK121282MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.K102083VELSCOPE VXLed Dental, Inc.K101140DENTLIGHT ORAL EXAM LIGHT KITDentlight, Inc.K090135TRIMIRA IDENTAFI 3000Remicalm, LLCK082668BIO-SCREENAddent, 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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