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FDA 510(k)

IL0292 DP ECHOPORT

K-Number: K970555 · 1997-03-17

ApplicantSmith
Decision Date1997-03-17
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IL0292 DP ECHOPORT is the device name listed in this FDA 510(k) record. The listed applicant is Smith. It received FDA 510(k) clearance on 1997-03-17 under 510(k) number K970555. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL0292 DP ECHOPORT?

IL0292 DP ECHOPORT is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Smith. The 510(k) number is K970555.

When did IL0292 DP ECHOPORT receive FDA 510(k) clearance?

IL0292 DP ECHOPORT received FDA 510(k) clearance on 1997-03-17, under 510(k) number K970555.

Who is the listed applicant for IL0292 DP ECHOPORT?

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

What is the FDA product code for IL0292 DP ECHOPORT?

The FDA product code for IL0292 DP ECHOPORT is EWO.

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Other records listing Smith 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.

K973747CONTROLLED TEMPERATURE CABINET SYSTEMK973748TEMPO AND TEMP H20K972123PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905K971092QA-ES

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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