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FDA 510(k)

ULTRAMARK 4 ULTRASOUND SYS

K-Number: K842376 · 1984-10-05

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1984-10-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAMARK 4 ULTRASOUND 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 1984-10-05 under 510(k) number K842376. 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 ULTRAMARK 4 ULTRASOUND SYS?

ULTRAMARK 4 ULTRASOUND SYS is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K842376.

When did ULTRAMARK 4 ULTRASOUND SYS receive FDA 510(k) clearance?

ULTRAMARK 4 ULTRASOUND SYS received FDA 510(k) clearance on 1984-10-05, under 510(k) number K842376.

Who is the listed applicant for ULTRAMARK 4 ULTRASOUND 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 ULTRAMARK 4 ULTRASOUND SYS?

The FDA product code for ULTRAMARK 4 ULTRASOUND SYS is IYO.

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Other records listing Advanced Technology Laboratories, Inc. as applicant

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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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