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FDA 510(k)

VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL

K-Number: K122429 · 2012-11-28

ApplicantObject Research Systems (Ors), Inc.
Decision Date2012-11-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL is the device name listed in this FDA 510(k) record. The listed applicant is Object Research Systems (Ors), Inc.. It received FDA 510(k) clearance on 2012-11-28 under 510(k) number K122429. 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 VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL?

VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL is a medical device that received FDA 510(k) clearance on 2012-11-28. The listed applicant is Object Research Systems (Ors), Inc.. The 510(k) number is K122429.

When did VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL receive FDA 510(k) clearance?

VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL received FDA 510(k) clearance on 2012-11-28, under 510(k) number K122429.

Who is the listed applicant for VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL?

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

What is the FDA product code for VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL?

The FDA product code for VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL is LLZ.

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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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