FDA 510(k)

ECHO-COMP

K-Number: K800766 · 1980-04-24

Decision Date1980-04-24

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECHO-COMP is the device name listed in this FDA 510(k) record. The listed applicant is Digisonics, Inc.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800766. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO-COMP?

ECHO-COMP is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Digisonics, Inc.. The 510(k) number is K800766.

When did ECHO-COMP receive FDA 510(k) clearance?

ECHO-COMP received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800766.

Who is the listed applicant for ECHO-COMP?

The FDA 510(k) record lists Digisonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHO-COMP?

The FDA product code for ECHO-COMP is DQK.

Other records listing Digisonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970402DOCTORS REVIEW SYSTEM K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK

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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.