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FDA 510(k)

OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM

K-Number: K022877 · 2003-02-05

ApplicantVision Chips, Inc.
Decision Date2003-02-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vision Chips, Inc.. It received FDA 510(k) clearance on 2003-02-05 under 510(k) number K022877. 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 OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM?

OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-05. The listed applicant is Vision Chips, Inc.. The 510(k) number is K022877.

When did OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM receive FDA 510(k) clearance?

OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM received FDA 510(k) clearance on 2003-02-05, under 510(k) number K022877.

Who is the listed applicant for OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM?

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

What is the FDA product code for OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM?

The FDA product code for OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM 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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