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FDA 510(k)

DIFOTI USB 2.0 SYSTEM

K-Number: K043068 · 2004-12-29

ApplicantElectro-Optical Sciences, Inc.
Decision Date2004-12-29
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIFOTI USB 2.0 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Optical Sciences, Inc.. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K043068. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIFOTI USB 2.0 SYSTEM?

DIFOTI USB 2.0 SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Electro-Optical Sciences, Inc.. The 510(k) number is K043068.

When did DIFOTI USB 2.0 SYSTEM receive FDA 510(k) clearance?

DIFOTI USB 2.0 SYSTEM received FDA 510(k) clearance on 2004-12-29, under 510(k) number K043068.

Who is the listed applicant for DIFOTI USB 2.0 SYSTEM?

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

What is the FDA product code for DIFOTI USB 2.0 SYSTEM?

The FDA product code for DIFOTI USB 2.0 SYSTEM is NTK.

Related Clinical Trials

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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Other records listing Electro-Optical Sciences, 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.

K991098DIFOTI SYSTEM

Related Devices (Code: NTK)

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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