FDA 510(k)

TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX

K-Number: K801972 · 1980-10-23

ApplicantAdvanced Technology Laboratories, Inc.

Decision Date1980-10-23

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX 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 K801972. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX?

TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX 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 K801972.

When did TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX receive FDA 510(k) clearance?

TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX received FDA 510(k) clearance on 1980-10-23, under 510(k) number K801972.

Who is the listed applicant for TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX?

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 TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX?

The FDA product code for TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.