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FDA 510(k)

IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA

K-Number: K801973 · 1980-10-23

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1980-10-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA 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 1980-10-23 under 510(k) number K801973. 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 IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA?

IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K801973.

When did IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA receive FDA 510(k) clearance?

IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801973.

Who is the listed applicant for IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA?

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 IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA?

The FDA product code for IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA 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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