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FDA 510(k)

SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS

K-Number: K991302 · 1999-06-01

ApplicantSmartlight, Inc.
Decision Date1999-06-01
Product CodeIXC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Smartlight, Inc.. It received FDA 510(k) clearance on 1999-06-01 under 510(k) number K991302. The device is classified under product code IXC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS?

SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS is a medical device that received FDA 510(k) clearance on 1999-06-01. The listed applicant is Smartlight, Inc.. The 510(k) number is K991302.

When did SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS receive FDA 510(k) clearance?

SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS received FDA 510(k) clearance on 1999-06-01, under 510(k) number K991302.

Who is the listed applicant for SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS?

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

What is the FDA product code for SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS?

The FDA product code for SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS is IXC.

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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Related Devices (Code: IXC)

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.

K973965SMART MOTORIZED VIEWERSmartlight, Ltd.K973115ARRIPRO 35 ST/TVArnold & Richter Cine TechnikK970240DIFFUSER PANELFocused Viewer, Inc.K954998LILY DARK VIEWERLily Imaging Solutions Co.K954199VOXBOXVoxelK952188ADVIEWER 2000Adp , Ltd.

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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