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FDA 510(k)

ARTOSCAN S

K-Number: K981358 · 1998-07-13

ApplicantBiosound Esaote, Inc.
Decision Date1998-07-13
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTOSCAN S 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 1998-07-13 under 510(k) number K981358. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTOSCAN S?

ARTOSCAN S is a medical device that received FDA 510(k) clearance on 1998-07-13. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K981358.

When did ARTOSCAN S receive FDA 510(k) clearance?

ARTOSCAN S received FDA 510(k) clearance on 1998-07-13, under 510(k) number K981358.

Who is the listed applicant for ARTOSCAN S?

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 ARTOSCAN S?

The FDA product code for ARTOSCAN S is LHN.

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Other records listing Biosound Esaote, 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.

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Related Devices (Code: LHN)

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, 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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