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FDA 510(k)

DIFOTI SYSTEM

K-Number: K991098 · 1999-06-30

ApplicantElectro-Optical Sciences, Inc.
Decision Date1999-06-30
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIFOTI 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 1999-06-30 under 510(k) number K991098. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIFOTI SYSTEM?

DIFOTI SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-30. The listed applicant is Electro-Optical Sciences, Inc.. The 510(k) number is K991098.

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

DIFOTI SYSTEM received FDA 510(k) clearance on 1999-06-30, under 510(k) number K991098.

Who is the listed applicant for DIFOTI 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 SYSTEM?

The FDA product code for DIFOTI SYSTEM is EIA.

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.

K043068DIFOTI USB 2.0 SYSTEM

Related Devices (Code: EIA)

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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