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FDA 510(k)

ORS VISUAL

K-Number: K100335 · 2010-04-08

ApplicantObject Research Systems, Inc.
Decision Date2010-04-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORS VISUAL is the device name listed in this FDA 510(k) record. The listed applicant is Object Research Systems, Inc.. It received FDA 510(k) clearance on 2010-04-08 under 510(k) number K100335. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORS VISUAL?

ORS VISUAL is a medical device that received FDA 510(k) clearance on 2010-04-08. The listed applicant is Object Research Systems, Inc.. The 510(k) number is K100335.

When did ORS VISUAL receive FDA 510(k) clearance?

ORS VISUAL received FDA 510(k) clearance on 2010-04-08, under 510(k) number K100335.

Who is the listed applicant for ORS VISUAL?

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

What is the FDA product code for ORS VISUAL?

The FDA product code for ORS VISUAL is LLZ.

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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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