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FDA 510(k)

ATL'S MARK 100/300 ULTRASOUND SYSTEMS

K-Number: K811572 · 1981-08-10

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1981-08-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATL'S MARK 100/300 ULTRASOUND SYSTEMS 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 1981-08-10 under 510(k) number K811572. 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 ATL'S MARK 100/300 ULTRASOUND SYSTEMS?

ATL'S MARK 100/300 ULTRASOUND SYSTEMS is a medical device that received FDA 510(k) clearance on 1981-08-10. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K811572.

When did ATL'S MARK 100/300 ULTRASOUND SYSTEMS receive FDA 510(k) clearance?

ATL'S MARK 100/300 ULTRASOUND SYSTEMS received FDA 510(k) clearance on 1981-08-10, under 510(k) number K811572.

Who is the listed applicant for ATL'S MARK 100/300 ULTRASOUND SYSTEMS?

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 ATL'S MARK 100/300 ULTRASOUND SYSTEMS?

The FDA product code for ATL'S MARK 100/300 ULTRASOUND SYSTEMS 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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