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FDA 510(k)

E-SCAN

K-Number: K990968 · 1999-05-27

ApplicantBiosound Esaote, Inc.
Decision Date1999-05-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

E-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Biosound Esaote, Inc.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K990968. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-SCAN?

E-SCAN is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K990968.

When did E-SCAN receive FDA 510(k) clearance?

E-SCAN received FDA 510(k) clearance on 1999-05-27, under 510(k) number K990968.

Who is the listed applicant for E-SCAN?

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

What is the FDA product code for E-SCAN?

The FDA product code for E-SCAN is LNH.

Other records listing Biosound Esaote, 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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