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FDA 510(k)

MARK 100 & 300 ULTRASOUND SYSTEM

K-Number: K820365 · 1982-03-26

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1982-03-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MARK 100 & 300 ULTRASOUND 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 1982-03-26 under 510(k) number K820365. 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 100 & 300 ULTRASOUND SYSTEM?

MARK 100 & 300 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K820365.

When did MARK 100 & 300 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

MARK 100 & 300 ULTRASOUND SYSTEM received FDA 510(k) clearance on 1982-03-26, under 510(k) number K820365.

Who is the listed applicant for MARK 100 & 300 ULTRASOUND 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 100 & 300 ULTRASOUND SYSTEM?

The FDA product code for MARK 100 & 300 ULTRASOUND 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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