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FDA 510(k)

SMART MOTORIZED VIEWER

K-Number: K973965 · 1997-12-12

ApplicantSmartlight, Ltd.
Decision Date1997-12-12
Product CodeIXC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMART MOTORIZED VIEWER is the device name listed in this FDA 510(k) record. The listed applicant is Smartlight, Ltd.. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K973965. 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 SMART MOTORIZED VIEWER?

SMART MOTORIZED VIEWER is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Smartlight, Ltd.. The 510(k) number is K973965.

When did SMART MOTORIZED VIEWER receive FDA 510(k) clearance?

SMART MOTORIZED VIEWER received FDA 510(k) clearance on 1997-12-12, under 510(k) number K973965.

Who is the listed applicant for SMART MOTORIZED VIEWER?

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

What is the FDA product code for SMART MOTORIZED VIEWER?

The FDA product code for SMART MOTORIZED VIEWER is IXC.

Related Clinical Trials

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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.

K991302SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUSSmartlight, Inc.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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