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FDA 510(k)

MARK V DUPLEX ULTRASONIC SCAN SYS.

K-Number: K802438 · 1981-01-21

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1981-01-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MARK V DUPLEX ULTRASONIC SCAN SYS. 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 1981-01-21 under 510(k) number K802438. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK V DUPLEX ULTRASONIC SCAN SYS.?

MARK V DUPLEX ULTRASONIC SCAN SYS. is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K802438.

When did MARK V DUPLEX ULTRASONIC SCAN SYS. receive FDA 510(k) clearance?

MARK V DUPLEX ULTRASONIC SCAN SYS. received FDA 510(k) clearance on 1981-01-21, under 510(k) number K802438.

Who is the listed applicant for MARK V DUPLEX ULTRASONIC SCAN SYS.?

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 V DUPLEX ULTRASONIC SCAN SYS.?

The FDA product code for MARK V DUPLEX ULTRASONIC SCAN SYS. is ITX.

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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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