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FDA 510(k)

MARK III ULTRASONIC SCANNING SYSTEM

K-Number: K801406 · 1980-07-28

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1980-07-28
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MARK III ULTRASONIC SCANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801406. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK III ULTRASONIC SCANNING SYSTEM?

MARK III ULTRASONIC SCANNING SYSTEM is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K801406.

When did MARK III ULTRASONIC SCANNING SYSTEM receive FDA 510(k) clearance?

MARK III ULTRASONIC SCANNING SYSTEM received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801406.

Who is the listed applicant for MARK III ULTRASONIC SCANNING SYSTEM?

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

What is the FDA product code for MARK III ULTRASONIC SCANNING SYSTEM?

The FDA product code for MARK III ULTRASONIC SCANNING SYSTEM is IYO.

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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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